87 Jobs für Drug Regulatory Affairs
Stellenangebote Drug Regulatory Affairs Jobs
Job vor 14 Tagen bei Jobleads gefunden
• München, Bayern
Flexible Arbeitszeiten Betriebliche Altersvorsorge
[. .. ] interner Abläufe und stelle exzellente Qualitätsstandards sicher, um unsere strategischen Ziele zu erreichen Das solltest du mitbringen Ein erfolgreich abgeschlossenes Pharmazie-/ Medizinstudium oder ein naturwissenschaftliches Studium Erste [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Berufserfahrung im Bereich Drug Regulatory Affairs, idealerweise im globalen Umfeld Sehr gute Englisch- und Deutschkenntnisse in Wort und Schrift Kommunikationsstärke und hoher Teamspirit sowie Freude daran, mit unterschiedlichen Kulturen zusammenzuarbeiten Eine sehr strukturierte, eigenständige sowie konzeptionelle Denk- und Arbeitsweise Ein ausgeprägtes Verantwortungsbewusstsein, um Aufgaben mit einem ganzheitlichen Ansatz zu verfolgen und erfolgreich bis zum Abschluss zu [. .. ]
Job am 05.03.2026 bei Jobleads gefunden
Associate Director, EUCAN Regulatory Lead-GI and Inflammation
• Zürich
Führungs-/ Leitungspositionen
[. .. ] activities for meetings with Health Authorities. Education, Behavioral Competencies and Skills BSc. Advanced scientific related degree preferred; BA accepted based on experience. A minimum of 8 years [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] of experience in drug regulatory affairs preferably within the EU/ GEM region. Solid regulatory experience, including knowledge of regulations and guidance applicable in the region across all phases of development and able to orient project teams in the interpretation of guidelines; an understanding of basic regulatory requirements in other regions globally (US, EU, Emerging markets) is [. .. ]
Job am 05.03.2026 bei Jobleads gefunden
• Zürich
Führungs-/ Leitungspositionen
[. .. ] Zurich, Switzerland. This role involves leading regional regulatory strategies for assigned assets, ensuring timely submissions and approvals throughout product development. The ideal candidate will have at least [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] eight years of drug regulatory affairs experience and the ability to manage complex regulatory issues. Excellent communication skills and a collaborative approach are essential for success in this position. #J-18808-Ljbffr 82940632 [. .. ]
Job vor 2 Tagen bei StepStone gefunden
Otsuka Pharma GmbH
Associate Director Global Regulatory Affairs (m/f/d)
• Frankfurt am Main
Führungs-/ Leitungspositionen Beratungs-/ Consultingtätigkeiten
[. .. ] and Western values. An inspiring environment for people who are open to innovation and creativity and want to make a difference together For Otsuka Pharma Gmb H [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] in the department Global Regulatory Affairs we are looking for a full-time employee to start as soon as possible as Associate Director Global Regulatory Affairs (m/f/d) The Associate Director Regulatory Affairs provides global regulatory expertise to pre-clinical, clinical, and commercial areas for investigational and marketed products and he ensures that regulatory/ competitive [. .. ] documents for submission and final approval. The key responsibilities of this position are: Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior Director or Executive Director or Head of Region Europe Ensuring the primary contact to Competent Authorities within Europe and other regions as required Identifying the need and obtaining regulatory intelligence, researching [. .. ]
Job am 06.02.2026 bei StepStone gefunden
Dr. Falk Pharma GmbH
• Freiburg
Führungs-/ Leitungspositionen Homeoffice möglich
[. .. ] of Global Safety/ EU/ UK QPPV/ Graduated Plan Officer in the fulfillment of pharmacovigilance obligations, including Collection, systematic documentation and evaluation of all necessary information in connection [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] with indications of drug risks, in particular adverse drug reactions, interactions and contraindications, as well as indications of quality defects, misuse, long-term use, abuse or counterfeit drugs Medical/ scientific assessment of drug risks and their documentation, taking into account the statutory reporting obligations to the competent authorities Passing on necessary information to pharmacovigilance [. .. ] Pharma Gmb Hs medicinal products to the responsible EU/ UK authorities Overview of periodic reconciliations with partners and subsidiaries as well as internal reconciliations with the Quality and Medical Scientific Affairs departments Carrying out a continuous assessment of the benefit-risk profile as part of signal management Conducting PV training for employees of Dr. Falk Pharma Gmb H, sales partners and subsidiaries Preparation of periodic safety reports (PSUR/ DSUR) Preparation of risk management plans including the coordination of risk-minimizing measures Approval and release of PASS protocols Support and advice in the preparation of regulatory submissions Contact person for the competent EU/ UK authorities on a 24/ 7 basis Contact person for GVP inspections Supervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documents Your qualification Successfully completed degree in pharmacy or human [. .. ]
Job vor 3 Tagen bei Neuvoo.com gefunden
Vetter Pharma- Fertigung GmbH Co. KG
Regulatory Affairs Specialist (m/w/d)
• Baden- Württemberg
Betriebliche Altersvorsorge 30+ Urlaubstage Work-Life-Balance
[. .. ] internationalen Vorgaben (z. B. EMA, FDA) Sie arbeiten eng mit internationalen Kunden im Rahmen von Projekten und über den gesamten Produktlebenszyklus hinweg Sie übernehmen die Erstellung und [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] regelmäßige Überarbeitung von Drug Master Files zu unseren Vetter-Verschlusssystemen (z. B. V-LK S, V-OVS) entsprechend den Anforderungen internationaler Zulassungsbehörden Sie sind Ansprechpartner für Behördenanfragen, Mängelschreiben sowie Kunden- und interne Anfragen zu regulatorischen Themen Sie gestalten aktiv mit, indem Sie regulatorische Themen intern und extern präsentieren, Informationsveranstaltungen und Schulungen durchführen, sowie Projekte [. .. ] Sie unser Team komple Mit Ihrem abgeschlossenen Pharmaziestudium oder naturwissenschaftlichen bzw. technischen Studium Mit Ihrer ersten Berufserfahrung in einem regulierten Umfeld, idealerweise im GMP-Bereich Durch Ihrer Zusatzqualifikation im Bereich Regulatory Affairs (z. B. DGRA) von Vorteil Durch Ihre verhandlungssicheren Englischkenntnisse in Wort und Schrift Mit Ihrer analytischen und strukturierten Arbeitsweise zur Sicherstellung unserer hohen Qualitätsstandards Durch Ihre Teamfähigkeit sowie Ihre ausgeprägte Kunden- und Partnerorientierung Mit Ihren guten Deutschkenntnissen (mind. C1-Level) , damit Sie Ihre Arbeit optimal dokumentieren und sich mit [. .. ]
Job vor 2 Tagen bei Mindmatch.ai gefunden
United Nations
• AT- 9 Wien
This position is located in the Office of the Secretary (OS) , Secretariat of the International Narcotics Control Board (INCB) , Division for Treaty
Affairs (DTA) , United Nations Office [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] on Drugs and Crime (UNODC) , in Vienna. The incumbent will report to the Global Rapid Interdiction of Dangerous Substances (GRIDS) Programme Management Officer. The Secretariat of the INCB is an administrative entity of UNODC reporting directly to the Board on substantive matters. For more [. .. ] national bodies through automated collection, compilation, analysis, visualization, and exchanges involving drugs, new psychoactive substances (NPS) and related chemicals using machine learning algorithms; Coordinate, maintain, refine and operationalize INCB proprietary drug control reporting technologies under the GRIDS Programme (Project Ion Incident Communication System IONICS) , GRIDS Intelligence, Scanning Novel Opioids Online Platforms (SNOOP) , etc) with internal stakeholders, relevant national, regional and international stakeholders and relevant private sector partners, to ensure flow of information; Support the development, management, use and promotion [. .. ] responsible professional work experience including at the international level, in government or private sector positions in areas related to machine learning data analytics for drug or chemical control, law or regulatory enforcement, or related field is required. Work experience at national or international drug or precursor law, regulatory or postal enforcement agencies in promoting inter-agency coordination/ cooperation at the national and international levels with relevant authorities and private sector partners is required. Work experience developing self-service analytics and data [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Principal Consultant Regulatory Strategist
• München, Bayern
Beratungs-/ Consultingtätigkeiten
[. .. ] are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Summary Principal Consultant Regulatory Strategist brings scientific depth and regulatory foresight to product and business strategy anticipating regulatory and policy trends, shaping development paths, and enabling commercial advantage. This role is defined by influence: partnering with the rest of the regulatory strategy team, CMC, clinical strategy, clinical operations, quality, legal and commercial leaders to [. .. ] and deepen Aliras scientific and strategic regulatory capabilities by bringing advanced regulatory science expertise, analytical foresight, and cross-functional integration to complex development programs. Working together with the SVP Regulatory Affairs, this role enhances the quality, rigor, and forward-looking dimension of regulatory strategy, supporting optimized development pathways, robust authority engagement preparation, and defensible scientific positioning. This role complements and reinforces the existing regulatory leadership structure and contributes to elevating regulatory thinking as a competitive advantage for clients. Job Description As [. .. ] and scenario planning) to identify emerging regulatory, policy and scientific trends and translate these into actionable recommendations for clients and internal teams. Develop and lead global regulatory strategies for client drug development programs. Co-create integrated development strategies and regulatory roadmaps that align scientific design, clinical strategy, CMC and commercial when appropriate to support clients objectives. Explore alternative pathways that optimize use of Agency tools, programs to enhance the development journey and lifecycle value in particular for early development projects. Advise [. .. ]
Job vor 11 Tagen bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] leadership and fostering high-level engagement with the scientific community and healthcare ecosystem stakeholders. As a License to Operate (LTO) Champion, the CMD integrates critical functions such as [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] clinical operations, regulatory, quality, and safety to ensure medical compliance, superior patient outcomes, and the accelerated adoption of transformative medicines. Main Responsibilities Strategic Enterprise Leadership: Share responsibility for the affiliates enterprise strategy and long-term business objectives, ensuring competitive medical strategies are built on robust evidence generation and scientific data positioning. External Stakeholder [. .. ] specialized cross-functional teams. Main Requirements Educational Qualifications: A Medical Degree (MD) is required and other advanced degrees (e. g. , Pharm D, Ph D) are an advantage. Professional Experience: Profound Medical Affairs experience (minimum 5 years) including a solid understanding of drug development, commercialization, and healthcare compliance (GCP, GVP) . Strategic and Business Acumen: Demonstrated business and financial acumen, with the ability to operate successfully in a complex matrix environment with shared accountabilities. Leadership and Influencing at senior level: Strong evidence of leading with a vision using a coaching leadership approach. Has [. .. ]
Job vor 11 Tagen bei Jobleads gefunden
Country Medical Director, Roche Pharma Switzerland (RPS)
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] leadership and fostering high-level engagement with the scientific community and healthcare ecosystem stakeholders. As a License to Operate (LTO) Champion, the CMD integrates critical functions such as [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] clinical operations, regulatory, quality, and safety to ensure medical compliance, superior patient outcomes, and the accelerated adoption of transformative medicines. Main Responsibilities Strategic Enterprise Leadership: Share responsibility for the affiliates enterprise strategy and long-term business objectives, ensuring competitive medical strategies are built on robust evidence generation and scientific data positioning. External Stakeholder [. .. ] specialized cross-functional teams. Main Requirements Educational Qualifications: A Medical Degree (MD) is required and other advanced degrees (e. g. , Pharm D, Ph D) are an advantage. Professional Experience: Profound Medical Affairs experience (minimum 5 years) including a solid understanding of drug development, commercialization, and healthcare compliance (GCP, GVP) . Strategic and Business Acumen: Demonstrated business and financial acumen, with the ability to operate successfully in a complex matrix environment with shared accountabilities. Leadership and Influencing at senior level: Strong evidence of leading with a vision using a coaching leadership approach. Has [. .. ]
Job am 11.03.2026 bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description:The Vice President, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Europe and International Regulatory Affairs (APAC and New Markets, excluding USA, China and Japan) , is a leadership position that will be responsible for building and leading the regulatory groups to develop and implement regulatory strategies to secure and maintain market access for product (s) in line with business objectives and in coordination with key [. .. ] will sit on the GRA leadership team and represent regulatory on the European cross functional leadership team. Externally, the individual will interface with EMA, national regulators and international organizations regarding drug development and registration strategies and provide insights to the organization of evolving regulatory policy and its impact to Be One/ Beigenes business. He/ She also has line management, people development, and performance management responsibility across a broad geographic area. Essential Functions of the job: Establishes, develops, and manages effective/ high [. .. ]
Job am 11.03.2026 bei Jobleads gefunden
Global VP, Regulatory Affairs Europe International
• Basel, Basel- Stadt
A global biotechnology company is seeking a Vice President, Europe and International
Regulatory Affairs to lead regulatory strategy and teams in Europe and new markets. The role is responsible for [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] engaging with EMA and national regulators while ensuring compliance and high-quality submissions for drug development. The ideal candidate will have extensive experience in regulatory affairs within the pharmaceutical industry, strong leadership skills, and a strategic mindset. An excellent opportunity in a dynamic environment where innovation thrives. #J-18808-Ljbffr 83768473 [. .. ]
Job am 11.03.2026 bei Jobleads gefunden
Vice President, Regulatory Affairs, Europe and International
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Vice President, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Europe and International Regulatory Affairs (APAC and New Markets, excluding USA, China and Japan) , is a leadership position that will be responsible for building and leading the regulatory groups to develop and implement regulatory strategies to secure and maintain market access for product (s) in line with business objectives and in coordination with key [. .. ] will sit on the GRA leadership team and represent regulatory on the European cross functional leadership team. Externally, the individual will interface with EMA, national regulators and international organizations regarding drug development and registration strategies and provide insights to the organization of evolving regulatory policy and its impact to Be One/ Beigenes business. He/ She also has line management, people development, and performance management responsibility across a broad geographic area. Essential Functions of the job: Establishes, develops, and manages effective/ high [. .. ]
Job am 14.02.2026 bei Jobleads gefunden
Senior Director Medical Affairs-Neurology
• Ulm, Baden- Württemberg
Führungs-/ Leitungspositionen
[. .. ] asset. Provides guidance, direction and oversight for the scientific/ medical leadership and partnership for late-stage development compounds and commercialized products. In partnership with head of neuroscience, represents [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Global Medical Affairs in strategic discussions regarding medical launch preparation, lifecycle management, business development, clinical research, and health economics and outcomes research planning. Acts as a strategic partner for business and clinical development. Develops AOP, LRP and manages budget effectively and proactively. Your experience and qualifications KNOWLEDGE: MD and specialty training and clinical, [. .. ] years pharmaceutical industry experience. Pharmaceutical industry experience in neurology. Experience in successfully developing strategy and executing medical plans, and in building professional external expert networks. Broad and good knowledge of drug development, clinical trial design, regulatory requirements, business development and life cycle management etc. SKILLS/ QUALIFICATIONS: Able to work in a changing and flexible environment with a strong patient focus and enterprise mindset. Experienced and adept at working collaboratively across different cross-functional teams such as commercial, R D, health outcomes, regulatory, pharmacovigilance and compliance and [. .. ]
Job am 02.02.2026 bei Jobleads gefunden
• München, Bayern
Führungs-/ Leitungspositionen
A Typical Day Might Include The Following Serve as the key Regeneron medical representative in Germany for internal stakeholders (Medical
Affairs, Clinical Development, Operations,
Regulatory, Commercial) and external [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] stakeholders (medical societies, academic institutions, key opinion leaders) . Represent Medical Affairs in crossfunctional internal meetings, partnering closely with global Therapeutic Area Medical Directors and Medical Affairs teams such as HEOR, Medical Education and Medical Information to optimize strategic and tactical planning. Provide medical leadership to clinical [. .. ] the pharmaceutical/ biotech industry, primarily in Medical Affairs leadership roles. Demonstrated leadership experience managing officebased and fieldbased Medical Affairs teams. Strong knowledge of the German healthcare ecosystem, regulatory landscape, and drug development processes. Proven ability to work effectively in a matrixed, crossfunctional environment and drive strategic medical plans. Outstanding medical communication skills, with the ability to deliver succinct, actionable insights. A track record of building and sustaining relationships with internal stakeholders and external experts. High scientific integrity, reliability, and the ability [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Director, Europe Patient Advocacy, Professional Relations, and Patient Engagement
• Zürich Zuerich
Führungs-/ Leitungspositionen
[. .. ] Represent Genmab in appropriate European forums and at major oncology congresses, collaborating with Medical, Commercial, and Alliance teams. Health Technology Assessment o Partner cross-functionally with Market Access/ [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] HEOR, Medical Affairs, Regulatory, Value Evidence, and Commercial teams to ensure the European patient voice is appropriately incorporated into HTA strategy and submissions, where relevant. o Build and sustain relationships with European and country-level patient organizations to support ethical, compliant, and meaningful inclusion of patient perspectives in evidence generation and HTA-aligned activities [. .. ] working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
• Planegg, Bayern
[. .. ] the integrity, accuracy, completeness, and quality of the clinical data from trial design through final database lock. This role partners cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Safety/ Pharmacovigilance, Regulatory Affairs, and CROs and external vendors to design, develop and implement a robust data management process that supports high-quality outcomes, timely database locks, and seamless data handoffs for reporting, analysis, and regulatory submission. Your mission Lead clinical data management activities from study initiation through database lock. Develop, review and maintain [. .. ] Proficiency with EDC systems (i. e. , Medidata Rave) , including integration with Spotfire and familiarity with CDISC standards (SDTM) , and clinical coding dictionaries (e. g. , Med DRA, WHO Drug) . Excellent organizational, analytical, and communication skills, with a demonstrated ability to troubleshoot and resolve datarelated issues. Ability to thrive both independently and collaboratively in a fastpaced, crossfunctional environment. High attention to detail with a strong commitment to data accuracy, integrity, and quality. Oncology trial experience is a plus. Experience [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
Director (Regulation and Prequalification of Medicines and Health Products)
• Genf
Führungs-/ Leitungspositionen
Work-Life-Balance
[. .. ] are to ensure the quality, safety and efficacy of medicines and health products globally. The immediate strategic objective and priorities is to achieve greater country impact through [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] building capacity of Regulatory systems in LIMC, establishment of reliance mechanism among National Regulatory Authorities, and streamlining prequalification processes of qualityassured, safe and effective medicines and health products, thereby contributing to global health and sustainable development. RPQ department closely works with the Health Product Standards and Access (HPS) department in line with the WHO [. .. ] healthrelated science, or a relevant social science field related to the functions of the position. Desirable : A Ph D in one of the above-mentioned fields. Specialized training in regulatory affairs or pharmaceutical sciences. Certification in project management or health administration. Experience Essential : A minimum of 15 years of professional experience in the management of the Regulation and Prequalification of Medicines and Health Products programme, including experience providing senior level advice and guidance to Senior Management/ Decision makers, managing human [. .. ] of public health/ disease control programmes. Rich expertise and deep knowledge on the regulatory framework of medicines and health products, i. e. European Medicines Agency (EMA) , US Food and Drug Administration (USFDA) and other Stringent Regulatory Authorities. Extensive expertise in developing and implementing regulatory policies and strategies for medicines and health products, including greenfriendly products. Proven ability to engage and collaborate with diverse stakeholders, i. e. EMA, USFDA, AMA, UNICEF, UNFPA, etc. , to achieve common goals. Strong proficiency in [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
• Frankfurt, Hesse
Führungs-/ Leitungspositionen
Jobbeschreibung The Associate Director
Regulatory Affairs provides global regulatory expertise to pre-clinical, clinical, and commercial areas for investigational and marketed products and he ensures that regulatory/ competitive intelligence, or [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] scientific/ regulatory information searching, summarization, assessment and dissemination are provided to the Otsuka organization. Furthermore the Associate Director Regulatory Affairs collaborates with Regulatory Management to establish [. .. ] documents for submission and final approval. The key responsibilities of this position are: Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior Director or Executive Director or Head of Region Europe Ensuring the primary contact to Competent Authorities within Europe and other regions as required Identifying the need and obtaining regulatory intelligence, researching [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
Senior Data Scientist Medical Analytics, Care Gaps Customer Segmentation Team
• Berlin
[. .. ] input required (e. g. , claims data for unmet need analysis) , and effective visualization/ insight generation for users. Plan, generate and perform assetspecific care gap analyses [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] to guide Medical Affairs activities using advanced techniques such as predictive models, machine learning, probabilistic causal models, and unsupervised algorithms. Create assetspecific HCP segments, maps, and prioritizations, across multiple dimensions including care gaps, to guide channel mix/ activation, content creation, and MSL activity in Anchor countries. Basic Qualifications Candidate demonstrates a breadth of diverse [. .. ] partner cross culturally/ regionally. Effective English verbal and written communication with flexibility to be clear, consistent, compliant, and appropriate for a variety of settings including scientific/ technical, promotional, patient/ consumer, regulatory, and media. In depth understanding of the business of pharmaceutical medicine including clinical trial design, GCP and data interpretation, drug development, regulatory and promotional rules/ guidance, legal and compliance, issue management and business development opportunity evaluations. Technical Anticipates Customer and Market Needs Knows the industry; knowledgeable in current and possible future trends, knows the competition; is aware of how strategies and tactics work in the marketplace. Is dedicated to meeting [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Regulatory CMC Consultant
• München, Bayern
Beratungs-/ Consultingtätigkeiten
[. .. ] topics from pre-clinical development to approved commercial products? If so, this could be the perfect opportunity for you We are recruiting for a CMC Consultant to join [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] a leading Regulatory Consultancy business based in Munich on a permanent basis. Our client offers full flexibility to manage your own workload within a professional and friendly working environment that is truly unique. The successful candidate will become the quality expert in our clients team, providing knowledge on broad range of drug substances from small molecules to synthetic oligonucleotides to biologicals, and drug products from solid orals to sterile solutions to nanoparticulate formulations. Responsibilities: Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team. Ensure that the content of [. .. ] regulatory guidance and regulations. Requirements: Ph D or masters degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable. At least five years in a scientific/ technical CMC development or CMC-regulatory affairs function. Experience with regulatory filings (INd/IMPD, BLA/ NDA/ MAA) . Excellent communication and negotiation skills in English. German language skills are a plus. Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial. Highly motivated team player with strong interpersonal abilities. [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Associate Director, GRA CMC Development
• Düsseldorf, Nordrhein- Westfalen Duesseldorf
Führungs-/ Leitungspositionen
LEAPING FORWARD TO MAKE PEOPLE SMILE At Kyowa Kirin International (KKI) , our purpose is to make people smile. This means more than
drug discovery and development; it is [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] about embedding care into everything we do to make a difference every day for those that need it most. Were an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to [. .. ] Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work. Job Purpose An experienced and autonomous regulatory professional responsible for independently leading CMC regulatory activities for assigned development products and clinical projects, including CGTs where applicable, while also serving as the recognized RA CMC expert for a specific product type, and/or country/ region. The role provides authoritative technical and/or regional regulatory insight that is leveraged [. .. ] regulatory leadership and support for Gx P inspections and audits related to development and manufacturing activities, including region-specific inspections where required. Qualifications Life science qualification with experience in pharmaceutical regulatory affairs. Demonstrated experience in pharmaceutical RA CMC, with a focus on development-stage biological products, including an understanding of CMC requirements across early to late stage clinical development. Experience leading global RA CMC strategies for biologics, including co-ordinating cross-functional input and ensuring alignment with program objectives. Experience leading CMC-[. .. ]
Job vor 4 Tagen bei Jobleads gefunden
Regulatory Affairs Lead (m/f/d)
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] established Swiss company with a strong track record as an innovative and reliable partner within the life sciences sector. On behalf of our client, we are currently [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] looking for a: Regulatory Affairs Lead (m/f/d) Location: Basel Metropolitan Area Position In this role, you will take a key position in the further development and strategic strengthening of the Regulatory Affairs function. You will combine handson regulatory work with strategic oversight and ensure that regulatory requirements across multiple product categories are managed [. .. ] development and global business activities. Tasks Development and continuous improvement of the global Regulatory Affairs strategy with a focus on pharmaceutical APIs Regulatory oversight of relevant dossiers and documentation, including Drug Master Files (DMFs) , ASMFs, CEPs and technical documentation Interaction with health authorities and coordination of regulatory responses and submissions Responsibility for labeling governance and regulatory claims across different product categories Providing regulatory input for new product development projects and product lifecycle management Selection, coordination and management of external regulatory [. .. ]
Job vor 6 Tagen bei Jobleads gefunden
Clinical Research Associate
• München, Bayern
[. .. ] in accordance with ICHGCP, Alexion SOPs and local requirements. Supporting/ participating in regular QC checks of the e TMF In some countries, as required, CRAs are accountable [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] for study startup and regulatory maintenance. Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/ documents to EC/ IRB and to Regulatory Authorities for startup and for the duration of the study. Contributing to the nomination and selection of potential investigators and assisting with feasibility activities Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders, as needed. Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICHGCP compliance issues to Global Study team, Local study team, Country Operations Line Management and/or Quality Group, representatives as required. Preparing for and collaborating [. .. ] of international guidelines ICHGCP, basic knowledge of GMP/ GDP. Excellent knowledge of relevant local regulations. Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas. Good understanding of the drug development process. Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management. Excellent attention to details. Excellent written and verbal communication skills. Excellent collaboration and interpersonal skills. Good negotiation skills. Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70 [. .. ]
Job vor 7 Tagen bei Jobleads gefunden
Senior Product Manager, Germany (contract)
• Berlin
[. .. ] that promotional campaigns are appropriately developed and executed effectively, close contacts with other LOCs to share and promote best practices across countries. Work closely with all supporting [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] functions (including medical, regulatory, sales and international marketing) . Cross-functional collaboration with the responsible managers and colleagues in the creation and implementation of marketing plans. Drive effective and efficient cross-functional collaboration and alignment with partners including sales, advocacy, corporate affairs, business analytics, legal, regulatory and compliance to appropriately meet or exceed brand objectives. Ensure legal/ regulatory compliance and medical accuracy of all marketing materials. Translate the brand science and strategy into patient-friendly terms to make a positive impact on patients lives. Interface and present to senior leadership on performance [. .. ] problems, with a focus on allergy/ inflammation and oncology/ hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a track record of success, leveraging our established research, development, and commercial capability and infrastructure, we aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases and [. .. ]
1 von 4Weiter » Weitere Suchergebnisse laden »
Häufig gestellte Fragen
Wieviel verdient man als Drug Regulatory Affairs pro Jahr?
Als Drug Regulatory Affairs verdient man zwischen EUR 60.000,- bis EUR 90.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Drug Regulatory Affairs Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 87 offene Stellenanzeigen für Drug Regulatory Affairs Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Drug Regulatory Affairs Jobs?
Aktuell suchen 21 Unternehmen nach Bewerbern für Drug Regulatory Affairs Jobs.
Welche Unternehmen suchen nach Bewerbern für Drug Regulatory Affairs Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Drug Regulatory Affairs Stellenangebote:
- Dr. Falk Pharma GmbH (3 Jobs)
- Parexel (2 Jobs)
- Otsuka Pharma GmbH (1 Job)
- Vetter Pharma- Fertigung GmbH Co. KG (1 Job)
- United Nations (1 Job)
- Advanced Resource Managers (1 Job)
In welchen Bundesländern werden die meisten Drug Regulatory Affairs Jobs angeboten?
Die meisten Stellenanzeigen für Drug Regulatory Affairs Jobs werden derzeit in Bayern (21 Jobs), Berlin (13 Jobs) und Baden-Württemberg (9 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Regulatory Affairs Jobs?
Drug Regulatory Affairs Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
