174 Jobs für Drug Regulatory Affairs
Stellenangebote Drug Regulatory Affairs Jobs
Job am 09.10.2025 bei Jobleads gefunden
• München, Bayern
Beratungs-/ Consultingtätigkeiten
[. .. ] (m/w/d) in München Senior Consultant für Regulatory Reporting IT Solutions (w/m/d) in München Specialist Regulatory Affairs für Medizinprodukte (m/w/d) Werkstudent (m/w/d) Zulassung/
Drug Regulatory Affairs Senior Consultant [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Risk Regulatory (m/w/d) Projektstandorte München, Hamburg, Berlin, Frankfurt #J-18808-Ljbffr 65377361 [. .. ]
Job am 09.10.2025 bei Jobleads gefunden
Bauingenieur:in als Senior Projektleiter:in für Umbauten 80100
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
Flexible Arbeitszeiten Work-Life-Balance
[. .. ] Lead, RLT Senior Project Manager IT and Digitalisation Technical Project Manager HVAC, Cleanroom, EMS, ALC Manager Global Business Excellence--Temporary position Muttenz, Basel-Country, Switzerland 1 year ago Global [...]
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[...] Drug Regulatory Affairs Project Leader (6602) Associate Director, Technical Project Leader Drug Substance Senior Project Manager: Public Infrastructure Finance for Municipal Development Permanent contract Analytical Project Leader Senior/ Principal Scientist Lead, Real World Sciences Application Strategy m/f/d Drug Product Project Leader Oral Dosage Forms (80-100) Consultant Technology Transfer-Fill Finish [. .. ]
Job am 28.09.2025 bei Jobleads gefunden
• München, Bayern
Absolventen, Einsteiger, Trainees Abgeschlossenes Studium Abgeschlossene Ausbildung
Flexible Arbeitszeiten Betriebliche Altersvorsorge
[. .. ] erreichen Das solltest du mitbringen: Ein erfolgreich abgeschlossenes Pharmazie-/ Medizinstudium oder ein naturwissenschaftliches Studium oder eine erfolgreich abgeschlossene Ausbildung aus dem medizinisch-technischem oder naturwissenschaftlichem Bereich Erste Berufserfahrung [...]
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[...] im Bereich Drug Regulatory Affairs, idealerweise im globalen Umfeld Sehr gute Englisch- und Deutschkenntnisse in Wort und Schrift; Französischkenntnisse auf Basisniveau wünschenswert 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 [. .. ]
Job am 11.07.2025 bei Jobleads gefunden
Regulatory Affairs Manager (m/w/d)
• Neuss, Nordrhein- Westfalen
Abgeschlossenes Studium
[. .. ] Aufgaben, und Sie verantworten zudem die Überwachung und Aktualisierung von Dokumenten zur Eignung der Prüfstelle. Sie können einen naturwissenschaftlichen Studienabschluss vorweisen sowie eine Zusatzausbildung im Bereich Regulatory [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Affairs (Master of Drug Regulatory Affairs, Master of Drug Research) oder bringen die Bereitschaft mit, eine solche Zusatzausbildung zeitnah zu erwerben. Die Bereitschaft zur kontinuierlichen Weiterbildung in einem sich schnell ändernden Umfeld ist für Sie selbstverständlich. Erste Berufserfahrung im Bereich Regulatory Affairs, insbesondere im Rahmen der Einreichung von Arzneimittel-Studien früher Phasen, würde die Einarbeitung erleichtern. [. .. ]
Job am 08.12.2025 bei Jobleads gefunden
• München, Bayern
Führungs-/ Leitungspositionen
[. .. ] role responsible for guiding safety strategy, ensuring compliance, and driving successful trial conduct for company assets across all stages of development. This be responsible for directing safety [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] strategy, operations, and regulatory compliance for oncology drug products across clinical development and commercialisation phases. This leadership role is central to ensuring safe, compliant, and successful oncology drug development and to maximising patient safety from clinical trials to post-marketing surveillance. This position will report to the Chief Medical Officer and either work on a hybrid basis from [. .. ] exchange agreements, and readiness for health authority inspections. Represent the company in safety-related interactions with regulatory agencies, partners, and external stakeholders. Collaborate cross-functionally with clinical development, regulatory, medical affairs, and other teams integrating safety across the product lifecycle. Ideally, you will have : A medical degree (MD, MBBS, DO) or equivalent clinical degree. 1215+ years experience in drug safety/ pharmacovigilance with at least 5 years at a senior leadership level in biotech and pharma, Oncology experience is required. Experience [. .. ]
Job am 04.12.2025 bei Jobleads gefunden
Lead Medical Director CVRm/Heart Failure
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] or Senior Medical Director will focus on guiding and shaping our cardiovascular outcomes strategy. To be successful in this role, you will need to have extensive experience [...]
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[...] in late stage drug development and managing large-scale clinical trials, including outcome studies, in particular we are looking for candidates with experience in heart failure programs. You will have strong collaboration with cross-functional teams, including clinical research, regulatory affairs, and medical affairs, to ensure the successful progression of treatments through the pipeline and into the market. The position would also require a strong understanding of cardiovascular diseases, clinical trial protocols, regulatory requirements, and possibly interactions with regulatory agencies to ensure studies meet the required standards. The Opportunity You will [. .. ]
Job am 04.12.2025 bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] or Senior Medical Director will focus on guiding and shaping our cardiovascular outcomes strategy. To be successful in this role, you will need to have extensive experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] in late stage drug development and managing large-scale clinical trials, including outcome studies, in particular we are looking for candidates with experience in heart failure programs. You will have strong collaboration with cross-functional teams, including clinical research, regulatory affairs, and medical affairs, to ensure the successful progression of treatments through the pipeline and into the market. The position would also require a strong understanding of cardiovascular diseases, clinical trial protocols, regulatory requirements, and possibly interactions with regulatory agencies to ensure studies meet the required standards. # # # [. .. ]
Job am 03.12.2025 bei Jobleads gefunden
Global Head of Drug and Patient Safety
• München, Bayern
Führungs-/ Leitungspositionen
[. .. ] Job Our client is a global, patient-focused biotechnology organisation dedicated to advancing innovative oncology therapies that improve outcomes for people living with cancer. Position Summary The Head [...]
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[...] of Global Drug Safety is a senior leadership role responsible for shaping and executing the companys worldwide pharmacovigilance strategy, with a strong emphasis on post-approval safety and risk management for oncology products. The Head ensures robust regulatory compliance, strengthens patient protection, and drives scientific and operational innovation throughout the post-approval lifecycle. As a key member of the governance leadership team, the Vice President plays an essential role in advancing the global safety strategy and maintaining the highest standards of patient safety. While clinical safety support is [. .. ] scientific, regulatory and industry forums to expand visibility and strengthen external partnerships. Regulatory Compliance Ensure all safety and pharmacovigilance activities meet global regulatory requirements and internal standards. Collaborate with Regulatory Affairs on safetyrelated submissions, PSURs and labelling updates for marketed and latestage products. Stay current with emerging global regulations and scientific advancements relevant to oncology safety. Provide strategic direction on regulatory interactions and inspection readiness related to safety and benefitrisk management. Risk Management Decision Making Deliver expert benefitrisk assessments to support [. .. ]
Job am 18.11.2025 bei Jobleads gefunden
• Wien
Führungs-/ Leitungspositionen
[. .. ] where feasible earlier adoption of our transformative medicines Foster a high-performance medical team culture, ensuring continuous professional growth and alignment with Roches leadership framework. Manage and oversee [...]
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[...] local Medical Affairs functions as well as Clinical Operations Champion our transformative medicines, facilitating their timely adoption and integration into clinical practice Oversee strategic evidence generation, value demonstration, and scientific data dissemination aligned with local market needs Who you are: Medical degree with significant clinical or pharmaceutical medical affairs experience is required Strong background in senior medical leadership, with comprehensive insight into drug development, commercialization, and medical compliance Proven ability to lead cross-functionally and strategically in complex environments Expertise in digital health is a plus Exceptional communication, negotiation, and stakeholder engagement skills Strong knowledge of local healthcare systems, regulatory and payer environments. Forward-thinking mindset, innovative approach, and excellent command of German and English We offer an annual salary starting from 120, 000, complemented by an attractive benefits package. This includes a competitive bonus scheme, participation in our stock program, pension contributions and more. Depending on your qualifications and [. .. ]
Job am 17.10.2025 bei Jobleads gefunden
Global Head of Pharmacovigilance
• Stuttgart, Baden- Württemberg
Führungs-/ Leitungspositionen
[. .. ] strategic leadership role responsible for guiding safety strategy, ensuring compliance, and driving successful trial conduct for company assets across all stages of development. This role directs safety [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] strategy, operations, and regulatory compliance for oncology drug products across clinical development and commercialisation phases. This leadership role is central to ensuring safe, compliant, and successful oncology drug development and to maximising patient safety from clinical trials to postmarketing surveillance. This position will report to the Chief Medical Officer and either work on a hybrid basis from the [. .. ] plans, data exchange agreements, and readiness for health authority inspections. Represent the company in safetyrelated interactions with regulatory agencies, partners, and external stakeholders. Collaborate crossfunctionally with clinical development, regulatory, medical affairs, and other teams integrating safety across the product lifecycle. Ideally, you will have : A medical degree (MD, MBBS, DO) or equivalent clinical degree. 1215+ years experience in drug safety/ pharmacovigilance with at least 5 years at a senior leadership level in biotech and pharma. Oncology experience is required. Experience [. .. ]
Job am 28.09.2025 bei Jobleads gefunden
Global Head of Pharmacovigilance
• Düsseldorf, Nordrhein- Westfalen
Führungs-/ Leitungspositionen
[. .. ] leadership role responsible for guiding safety strategy, ensuring compliance, and driving successful trial conduct for company assets across all stages of development. This role will direct safety [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] strategy, operations, and regulatory compliance for oncology drug products across clinical development and commercialisation Phases. This leadership role is central to ensuring safe, compliant, and successful oncology drug development and to maximising patient safety from clinical trials to post-marketing surveillance. This position will report to the Chief Medical Officer and can be based on a hybrid basis [. .. ] exchange agreements, and readiness for health authority inspections. Represent the company in safety-related interactions with regulatory agencies, partners, and external stakeholders. Collaborate cross-functionally with clinical development, regulatory, medical affairs, and other teams, integrating safety across the product lifecycle. Ideally, you will have : A medical degree (MD, MBBS, DO) or equivalent clinical degree. 1215+ years experience in drug safety/ pharmacovigilance with at least 5 years at a senior leadership level in biotech and pharma. Oncology experience is required. Experience [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Senior Logistics Compliance Specialist
• Barmelweid, Aargau
Homeoffice möglich
[. .. ] our people own their careers. Their ideas, big and small, genuinely improve the world. And thats the kind of work we want to be part of Our [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] team at Lonza Drug Product Services is growingand youre invited to grow with us We are looking for a highly experienced Process Expert in Logistics, with a strong GMP background, to take a functional lead in the Logistics Department, by defining and improving processes and systems to assure compliant and efficient logistics operations. If [. .. ] of all logistics and supply chain processes related to goods receipt, sampling, storage, and distribution within a GMP-regulated environment. Establish and maintain logistics SOPs in alignment with corporate and regulatory requirements. Lead local and cross-functional projects as Subject Matter Expert (SME) - from conceptual design through execution to successful completion. Represent the logistics function during regulatory inspections, customer audits, and client visits and presentations. Support deviation management and change control : act as second-level responsible for deviation investigations, [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
• Visp, Wallis
[. .. ] valid GMP manufacturing license. Ensure the traceability of all purchases and sales of pharmaceutical products and record the necessary information. Confirm that documentation proving the quality of [...]
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[...] traded batches of drug substance, intermediate drug product, and bulk product is complete. Independently decide on distribution stops and batch recalls when necessary. Manage quality and compliance risks. Approve all SOPs and other controlled documents related to the companys Healths licensed activities. Act as the primary contact for and approve all Technical/ Quality Agreements [. .. ] quality complaints. Report quality issues to Swiss Medic according to requirements and within established deadlines. Address quality issues with the responsible Supplier/ Manufacturing site. Stay up-to-date with Swiss regulatory requirements, authority organisations, processes, and the overall environment. Ensure awareness and implementation of applicable regulations and disseminate this information to relevant internal and external stakeholders. Act as the primary contact for all quality issues for Swiss Medic, the Cantonal Health Authority, and Third-Party Manufacturers. Plan and perform internal audits. [. .. ] education and experience of the Deputy Fv P and delegate tasks as appropriate. Qualifications Degree in Chemistry, Pharmacy, or Biology. 5+ years of experience exclusive in quality assurance, operations, or regulatory affairs. Supervisory or management experience is preferred. Strong knowledge of QA systems and Gx P compliance requirements, including regulations and standards for devices, biologics, and pharmaceutical products. Excellent written and verbal communication skills in both English and German. Demonstrated ability to think strategically to meet or exceed compliance and business needs. Strong [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Head of GMP Manufacturing (all genders)
• Taufkirchen, Bayern
Führungs-/ Leitungspositionen
[. .. ] time. About the Role The Head of Manufacturing is responsible for the strategic leadership and operational daytoday management of all manufacturing activities, utilities and systems and in [...]
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[...] accordance with applicable regulatory requirements and internal quality standards at the site in Taufkirchen near Munich, Germany. The position holder will be part of the site leadership team. Responsibilities Lead and direct the GMP Manufacturing department overseeing drug product manufacturing, including process development, scaleup, technology transfer, formulation operations, and GMP production Provide technical leadership and mentorship to crossfunctional teams and ensure alignment of technical strategy with production capabilities Drive continuous improvement of processes, yield, cost of goods, throughput, and capacity utilization by implementing robust process optimization and lean [. .. ] and GMP compliance (EU GMP, EMA, German regulatory bodies) in all operational and technical activities; ensure site readiness for audits and inspections Collaborate closely with Supply Chain, Quality Assurance, Regulatory Affairs, and Commercial teams to support product launch readiness and client commitments Qualifications Masters degree or Ph D in a scientific or engineering discipline Minimum of 10 years of experience in commercial or clinical manufacturing operations, including at least 5 years in a leadership role in a CDMO or (Bio) Pharma environment [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
• Mönthal, Aargau
Homeoffice möglich
[. .. ] our people own their careers. Their ideas, big and small, genuinely improve the world. And thats the kind of work we want to be part of Our [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] team at Lonza Drug Product Services is growingand youre invited to grow with us We are looking for a highly experienced Process Expert in Logistics, with a strong GMP background, to take a functional lead in the Logistics Department, by defining and improving processes and systems to assure compliant and efficient logistics operations. If [. .. ] of all logistics and supply chain processes related to goods receipt, sampling, storage, and distribution within a GMP-regulated environment. Establish and maintain logistics SOPs in alignment with corporate and regulatory requirements. Lead local and cross-functional projects as Subject Matter Expert (SME) - from conceptual design through execution to successful completion. Represent the logistics function during regulatory inspections, customer audits, and client visits and presentations. Support deviation management and change control : act as second-level responsible for deviation investigations, [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
Expert Toxicologist for Impurity Safety Assessment and Risk Management
• Penzberg, Bayern
[. .. ] and inspired to bring forward extraordinary lifechanging innovation at speed. This position is located in TSAC, a department within the Pharmaceutical Sciences function. We drive the nonclinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] safety assessment of drug candidates from small molecules to complex biological products during the discovery and development phases at Roche. The Opportunity We are offering an outstanding opportunity for a Senior Toxicologist to serve as the single point of contact for impurities assessments at Roche Basel. The position is placed in the Translational Safety [. .. ] the safety assessment of impurities and extractables/ leachables throughout the value chain from late discovery to clinical development, as well as for established medicines, with compliance to the most current regulatory guidelines. Utilizing your expertise, you will collaborate with crossfunctional teams to ensure the delivery of highquality and compliant safety evaluations. Your main responsibilities will be: You are the single point of contact for impurity and E L risk assessments in drug substances and drug products You conduct comprehensive risk assessments [. .. ] and cleaning validation procedures. You collaborate with crossfunctional teams to ensure control strategies are scientifically sound and compliant. You work closely with analytical chemists, formulation scientists, quality assurance, and regulatory affairs along with our Occupational Safety Teams. Your evaluations will be pivotal for the release of new batches from the manufacturing and quality functions You represent Roche as KOL in Industry Consortia and regulatory framework discussions groups You will advise and support project teams with regard to regulatory requests in the [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
Associate Director
Regulatory Affairs EMEA-Fixed Term Contract Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to [. .. ] the coordination between global and local regulatory partners Requirements: Minimum BS/ BA in life sciences Advanced degree preferred At least 8 years regulatory experience Sound knowledge of global regulatory framework, drug development and postapproval requirements Specific knowledge and experience of the regulatory requirements in the GCC region is required Travel requirements less than 10 Fluent in English; Arabic is a plus This position can be located either in UK, Switzerland or Dubai (Applicants must be in possession of a valid work [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Senior Regulatory Medical Writer-Oncology Leader
Führungs-/ Leitungspositionen
Work-Life-Balance
A leading biopharmaceutical solutions organization in Switzerland is seeking a Senior Principal Medical Writer to develop
regulatory documents and manage writing projects. The role involves mentoring junior writers and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] collaborating with cross-functional teams to deliver quality submissions. Ideal candidates will have demonstrated expertise in regulatory documentation and a solid understanding of the drug development process. The position offers competitive compensation and a range of benefits to promote work-life balance. #J-18808-Ljbffr 73264512 [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
• Frankfurt, Hesse
Weihnachtsgeld
[. .. ] Durchführung von Risikoanalysen sowie Ableitung und Nachverfolgung geeigneter Maßnahmen zur Risikominimierung Wissenschaftliche Begleitung und Unterstützung von Projekten während aller Transferphasen Erstellung und Konsolidierung von Dokumentationen für den [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Transfer neuer Arzneimittel (Drug Products) Sammlung, Strukturierung und Aufbereitung relevanter technischer und wissenschaftlicher Informationen Aktive Mitwirkung an lokalen Projekt- und Gremienroutinen, inklusive Protokollierung regelmäßiger Meetings Zusammenarbeit und fachlicher Austausch mit Expertinnen und Experten an internationalen Standorten Das bringen Sie mit Abgeschlossenes naturwissenschaftliches Studium, z. B. in Pharmazie, Biochemie, Chemie, Biotechnologie, Lebensmittelchemie, Chemieingenieurwesen oder vergleichbar [. .. ] und Herstellung pharmazeutischer Produkte, einschließlich injizierbarer Darreichungsformen Fundierte Kenntnisse und praktische Erfahrung im GMP-regulierten Umfeld Berufserfahrung in der pharmazeutischen Industrie, idealerweise in den Bereichen Produktion, Quality Assurance (QA) , Regulatory Affairs oder Qualitätskontrolle (QC) Ausgeprägte Team- und Kommunikationsfähigkeit sowie hohe Belastbarkeit und Flexibilität Verhandlungssichere Deutsch- und Englischkenntnisse in Wort und Schrift Das bietet Ihnen Permacon Unbefristeter Arbeitsvertrag 37, 5 Stunden/ Woche 60 hybrides Arbeiten nach Einarbeitung möglich Attraktive Vergütung inklusive Sonderzahlungen wie Urlaubs- und Weihnachtsgeld Strukturierte und umfassende Einarbeitung in Ihre [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Sr. Director, Head of Mid-Sized Countries, Europe
• Zug
Führungs-/ Leitungspositionen
[. .. ] of the operations and driving commercial success in those markets. Primary Responsibilities Strategic Planning: Develop, collaborate on, and implement strategic cross-functional plans for launching and commercializing the [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] rare disease drug in selected MSCs, ensuring alignment with overall company objectives, global brand strategy, allocated resources and market dynamics. Market Entry Strategy: Identify target segments within the MSC markets and develop comprehensive market entry strategies, considering regulatory requirements, reimbursement landscape, competitive landscape, and patient access pathways. Develop market access strategy with the support of Regional Market Access as well as local market access vendors. Successfully drive access and reimbursement. Cross-Functional Leadership: Collaborate closely with cross-functional teams including Marketing, Sales, Medical Affairs Patient Advocacy, Market Access, Regulatory Affairs, and Supply Chain to execute launch plans effectively and achieve business objectives. Stakeholder Engagement: In close collaboration with Medical Affairs build and maintain strong external networks and relationships with key stakeholders including healthcare professionals, patient advocacy groups, regulatory agencies, and payers in the selected [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Principal DP (Drug Product) Product Steward
• Penzberg, Bayern
[. .. ] support of the manufacturing network. Within PTT, Roches global Manufacturing Science and Technology (g MSAT) department is the process and product owner for our commercial products, including [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] our internal and external drug substance and drug product network, implementation of new technologies, network standardization, and mitigation of technical risks. The team is organized by product-focused Large Molecule and Small Molecule (DS DP) , Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams and operates in cross-functional [. .. ] industrialization as well as process development in the field of biological molecules. Significant crossfunctional matrix leadership experience Demonstrated experience with technology transfer and/or with process validation Strong understanding of regulatory submission and health authority requirements as well as patient needs/ patientcentricity as key elements of design and delivery Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity Where pay transparency applies, details are provided based on the primary posting location. [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Director, Market Access Marketing-Germany
Führungs-/ Leitungspositionen
Work-Life-Balance
[. .. ] and pricing outcomes for Genmabs oncology portfolio. This role requires strong expertise in market access and health economics, as well as effective collaboration with regional and global [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] teams in Medical Affairs, Regulatory Affairs, Commercial Operations, and Corporate Affairs, and engagement with HTA bodies, payers, policymakers, and key external stakeholders. # # Responsibilities # # # Market Access Reimbursement Develop, implement, and execute comprehensive German market access and reimbursement strategies for Genmabs oncology products. Lead the preparation and submission of value dossiers, [. .. ] 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 4 Tagen bei Jobleads gefunden
Sr. Director, Head of Mid-Sized Countries, Europe
• Zug
Führungs-/ Leitungspositionen
[. .. ] the operations and driving commercial success in those markets. Primary Responsibilities Strategic Planning : Develop, collaborate on, and implement strategic cross-functional plans for launching and commercializing the [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] rare disease drug in selected MSCs, ensuring alignment with overall company objectives, global brand strategy, allocated resources and market dynamics. Market Entry Strategy : Identify target segments within the MSC markets and develop comprehensive market entry strategies, considering regulatory requirements, reimbursement landscape, competitive landscape, and patient access pathways. Develop market access strategy with the support of Regional Market Access as well as local market access vendors. Successfully drive access and reimbursement. Cross-Functional Leadership : Collaborate closely with cross-functional teams including Marketing, Sales, Medical Affairs Patient Advocacy, Market Access, Regulatory Affairs, and Supply Chain to execute launch plans effectively and achieve business objectives. Stakeholder Engagement : In close collaboration with Medical Affairs build and maintain strong external networks and relationships with key stakeholders including healthcare professionals, patient advocacy groups, regulatory agencies, and payers in the [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Global C Q Director
• Wavre, Neuenburg
Führungs-/ Leitungspositionen
[. .. ] activities within the project portfolio under the accountability of Global Capital Projects group (GCP) . This role is responsible for ensuring that all project equipment, systems, and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] processes consistently meet regulatory and company standards to ensure product quality and patient safety. The Global C Q Director will work closely with cross-functional teams, including engineering, quality assurance, manufacturing, and regulatory affairs, to ensure the delivery of compliant and efficient commissioning and qualification programs. They will work to establish strong partnerships for efficient deployment of C Q capability and resources across all geographies. The Global C Q Director will drive towards best in class practices leveraging digital and AI to continuously improve [. .. ] validation project plans and results. In-depth knowledge of regulatory requirements and industry standards (e. g. , GMP, GAMP, ICH guidelines) . Experience in biopharm specific unit operations and platforms drug substance/ primary, DP/ sterile filling, and packaging. Strong project management skills, with experience in managing complex, multi-site projects. Deep and broad understanding of the capital project lifecycle design, construction, commissioning, qualification, to operation. Strong stakeholder management and influencing capabilities. Leadership skills that enable the introduction of new ways of [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Country Clinical Operations Head
• Zug
[. .. ] internal stakeholders to drive insightful and impactful interactions and promote the value of the clinical research team through the contribution to the R D portfolio success. Partners [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] with GMA Medical Affairs Head to co Lead the One R D collaboration within the affiliate. Operates as CDO Head to support and represent non CSM CDO personnel based within the affiliate. Accountable for the identification of resource needs, management of the allocated resources and timely hiring of clinical research staff to support clinical trials execution. [. .. ] clinical research, demonstrating a high level of expertise on study monitoring and management across multiple Therapeutic Areas, Study Phases and in fully cycle (startup to closeout) processes. Solid understanding of drug development process (and medical device preferred) and requirements such as GCP, ICH, etc. Robust knowledge of local clinical trial setting (regulatory and healthcare environment) . At least 2 years of experience in line management of staff including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams preferred. Proven track record in project management, strong planning and organizational skills and a high level [. .. ]
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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 174 offene Stellenanzeigen für Drug Regulatory Affairs Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Drug Regulatory Affairs Jobs?
Aktuell suchen 15 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:
- Veeda Lifesciences (11 Jobs)
- Bio Talent (11 Jobs)
- IQVIA (10 Jobs)
- Sanofi (2 Jobs)
- Parexel (2 Jobs)
- Gilead Sciences (1 Job)
In welchen Bundesländern werden die meisten Drug Regulatory Affairs Jobs angeboten?
Die meisten Stellenanzeigen für Drug Regulatory Affairs Jobs werden derzeit in Nordrhein-Westfalen (25 Jobs), Bayern (25 Jobs) und Sachsen (16 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Regulatory Affairs Jobs?
Drug Regulatory Affairs Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
