209 Jobs für Drug Regulatory Affairs
Stellenangebote Drug Regulatory Affairs Jobs
Job vor 8 Tagen bei Jobleads gefunden
• Glattbrugg, Zürich
[. .. ] communicates and manages meeting outcome and next steps, as required. Requirements: BSc. Advanced scientific related degree preferred; BA accepted based on experience. A minimum of 4 years [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] of experience in drug regulatory affairs preferably within the EU/ GEM region. Experience with advanced therapeutic medical products (Cell gene therapy) will be advantageous. Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in all phases of development for Emerging markets and/or EUCAN Markets (relevant to role) as well as leading [. .. ]
Job vor 8 Tagen bei Jobleads gefunden
Regulatory Affairs Manager-EU/ GEM Drug Development
• Glattbrugg, Zürich
[. .. ] managing regulatory activities throughout the product life cycle and communicating regulatory strategies. Candidates should possess a BSc or advanced scientific degree and a minimum of 4 years [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] of experience in drug regulatory affairs, ideally within the EU/ GEM regions. Strong communication and stakeholder management skills are essential. #J-18808-Ljbffr 71740484 [. .. ]
Job am 09.10.2025 bei Jobleads gefunden
• 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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 09.10.2025 bei Jobleads gefunden
Consultant Regulatory Management (w m d)
• 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 11.07.2025 bei Jobleads gefunden
• 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 vor 2 Tagen bei Neuvoo.com gefunden
Denk Pharma GmbH Co. KG
Manager (m/w/d) International Regulatory Affairs
• Munich Muenchen
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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 vor 2 Tagen bei Neuvoo.com gefunden
Denk Pharma GmbH Co. KG
• Munich Muenchen
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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 vor 11 Tagen bei Stellen-Online.de gefunden
Vetter Pharma- Fertigung GmbH Co. KG
Regulatory Affairs Specialist (m/w/d) - Vollzeit
• Ravensburg, 88212
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 komplett: 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 [. .. ]
Job vor 5 Tagen 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 vor 9 Tagen 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 [...]
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 vor 9 Tagen 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. The Opportunity You will [. .. ]
Job vor 10 Tagen 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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 vor 10 Tagen bei Jobleads gefunden
• Wien
Führungs-/ Leitungspositionen
[. .. ] and where feasible earlier adoption of our transformative medicines Foster a highperformance medical team culture ensuring continuous professional growth and alignment with Roches leadership framework. Manage and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] oversee 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. Forwardthinking mindset innovative approach and excellent command of German and English Key Skills EMR Systems Post Residency Experience Occupational Health Experience Clinical Research Managed Care Primary Care Experience Medical Management Utilization Management Clinical Development Clinical Trials Leadership Experience Medicare We offer an annual salary starting from 120000 [. .. ]
Job am 20.11.2025 bei Jobleads gefunden
Executive Director Medical Affairs-Hematology
• München, Bayern
Führungs-/ Leitungspositionen
Our Medical
Affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as an important liaison between Regeneron [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional area [. .. ] mindset is key as the offices are new and continuing to grow and evolve. The selected individual will work closely with the Heads of Commercial Oncology/ Hematology, Market Access, and Regulatory Affairs, including other key senior leaders within the international organization. A typical day might include the following: Representing Regeneron for International markets, for Hematology Medical Affairs and Clinical Development functions, excluding the USA and Japan. Overseeing and evolving a newly formed international medical team, bringing innovation and critical thinking to [. .. ] have 10+ years of oncology/ hematology experience in biotech/ pharma; other disease areas are a plus. Overall 20+ years of progressive industry/ relevant experience. You have a strong background in drug development and life-cycle development of related products. Experience working in a matrix, cross-functional environment and in alliance relationships is important and helpful. You can cultivate and maintain relationships with key internal and external stakeholders. Significant medical affairs pre-launch and launch experience in major markets (i. e. Europe [. .. ]
Job am 18.11.2025 bei Jobleads gefunden
• Wien
Führungs-/ Leitungspositionen
[. .. ] and where feasible earlier adoption of our transformative medicines Foster a highperformance medical team culture, ensuring continuous professional growth and alignment with Roches leadership framework. Manage and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] oversee 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 crossfunctionally 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. Forwardthinking 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 experience, [. .. ]
Job am 18.11.2025 bei Jobleads gefunden
Country Medical Director (Austria) (w/m/d)
• 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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 24.10.2025 bei Jobleads gefunden
• München, Bayern
Führungs-/ Leitungspositionen
[. .. ] our customers achieve their goals. The Senior Director, Quality and Compliance is responsible for compliance control and inspection readiness across TFS and will work according to company [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] policies, SOPs, and regulatory requirements. You will be accountable for strategy, performance/ delivery, compliance and operational results of the Quality Compliance department. Key Responsibilities Compliance Oversight Maintain expert-level knowledge of relevant regulations, Gx P standards, and internal procedures. Ensure company-wide compliance through proactive monitoring, communication, and implementation of regulatory requirements. Lead integration of [. .. ] other quality and compliance-related tasks as delegated. Qualifications University/ college degree in life science or equivalent Minimum 10 years experience in clinical research (e. g. , monitoring, data management, drug safety, training, etc. ) Minimum 10 years experience of auditing in two to three Gx P areas Minimum 10 years in compliance or relevant leadership role. Excellent knowledge of Gx P regulations and guidance. Awareness of global trends and government policies in the clinical trials area. Strong experience in driving quality 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 08.10.2025 bei Jobleads gefunden
• München, Bayern
[. .. ] Trials, Produktmanagement und Außendienst und schulst wissenschaftliche Inhalte nach innen und außen. Du hast ein erfolgreich abgeschlossenes medizinisches oder naturwissenschaftliches Studium. Du hast bereits 3 Jahre Berufserfahrung [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] im Bereich Medical Affairs oder in vergleichbaren Themenfeldern gesammelt. Du zeichnest Dich durch eine selbstständige und strukturierte Arbeitsweise aus, regelmäßige berufliche Reisen siehst Du als willkommene Abwechslung. Ausgeprägte Kommunikations- und Überzeugungsfähigkeit sowie Erfolgs- und Verkaufsorientierung gehören zu Deinen Stärken. Du besitzt sehr gute Deutsch- und Englischkenntnisse. VERTANICAL ist ein weltweit führendes Biopharmaunternehmen mit einer [. .. ] neues Leben Aus Gründen der besseren Lesbarkeit wird in dieser Anzeige die männliche Form verwendet. Sie bezieht sich ausdrücklich auf alle Geschlechter (w/m/d) . IT (Senior) Consultant für Regulatory Affairs, Medical Affairs oder Drug Safety-Life Science (w m d) Medical Science Liaison Hämatologie (all genders) für die Region Bayern Medical Science Liaison Hematology (München/ Nürnberg) (Sr) Medical Science Liaison Rare Diseases/ Friedreich Ataxie (FA) (f/m/d) Medical Science Liaison (m/w/d) Onkologie-Gastrointestinale Tumore (Norddeutschland) #J-18808-Ljbffr 65086292 [. .. ]
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 [. .. ]
Job am 26.09.2025 bei Jobleads gefunden
Executive Director Medical Affairs-Hematology
• München, Bayern
Führungs-/ Leitungspositionen
Executive Director Medical
Affairs-Hematology Our Medical Affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of [. .. ] mindset is key as the offices are new and continuing to grow and evolve. The selected individual will work closely with the Heads of Commercial Oncology/ Hematology, Market Access, and Regulatory Affairs, including other key senior leaders within the international organization. Responsibilities Representing Regeneron for International markets, for Hematology Medical Affairs and Clinical Development functions, excluding the USA and Japan. Overseeing and evolving a newly formed international medical team, bringing innovation and critical thinking to Medical Affairs processes. Drive functional excellence [. .. ] the European healthcare environment. 10+ years of oncology/ hematology experience in biotech/ pharma; other disease areas are a plus. Overall 20+ years of progressive industry/ relevant experience. Strong background in drug development and life-cycle development of related products. Experience working in a matrix, cross-functional environment and in alliance relationships is important and helpful. Ability to cultivate and maintain relationships with key internal and external stakeholders. Significant medical affairs pre-launch and launch experience in major markets (e. g. , [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
QA Responsible Person (RP) / Commercial Quality Assurance Head (6783)
• 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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 organizations, 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. [. .. ] Deputy Fv P and delegate tasks as appropriate. We are looking for someone with: 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
1480# Director Statistical Programming-Permanent Role
• Mainz, Rheinland- Pfalz
Führungs-/ Leitungspositionen
[. .. ] programmers or vendor CROs to ensure timely, high-quality delivery of analysis datasets, tables, listings, and figures (TLFs) across multiple clinical trials. Align programming strategies with compound/platform objectives [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and regulatory requirements (e. g. , CDISC standards, FDA/ EMA guidelines) . Drive the creation, review, and validation of SAS/ R programs for clinical data analysis, including SDTm/ADa M datasets, efficacy/ safety outputs, and integrated summaries. Ensure adherence to SOPs, regulatory standards, and reproducibility. Partner with Biostatistics, Clinical Development, Data Management, and Regulatory Affairs to shape clinical study designs, statistical analysis plans (SAPs) , and submission strategies to meet project deliverables and timelines for statistical data analysis and reporting. Represent programming in clinical study teams and other key meetings (e. g. , protocol reviews, submission readiness) . Lead the programming contribution to global regulatory [. .. ] FDA, EMA, ICH, and global regulations and guidelines. Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards. Solid understanding of the drug development process from early to latestage development and submission. Expertise in the requirements and technology to support electronic submissions. Strong interpersonal skills in addition to exceptional written and oral communication skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions. Strong analytical, project [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
CMC Compliance Strategy Manager-Integrations
• Aachen, Nordrhein- Westfalen
[. .. ] in integration projects are aligned with the integrations standards and priorities; Conduct CMC due diligence assessments and risk mitigation planning. Identify and resolve gaps in the CMC [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] documentation to ensure regulatory compliance during transitions; Ensures that the quality and manufacturing aspects of drug products and drug substances are integrated efficiently and in compliance with the global CMC regulatory standards; Develop CMC best practices and tools to optimize integration processes; Monitor timelines and deliverables to ensure successful execution of CMC workstreams within broader integration projects; Acts as primary business partner to senior leaders, managing [. .. ]
Job gestern bei Jobleads gefunden
Senior Manager, Regulatory Labelling
• Berlin
Job Title : Senior Manager,
Regulatory Labelling Location : Germany, Fully Remote Salary : Competitive Salary + Excellent Benefits Employee Type : Permanent As a Senior Manager, Regulatory Labelling, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] you will take leadership on everything related to Regulatory Labelling. This includes inputting from a regulatory labelling perspective on developing and established drug programs and being accountable for driving global labelling strategies. This is a challenging opportunity to demonstrate your knowledge in managing regulatory processes and supporting crossfunctional teams with endtoend labelling processes. Responsibilities Support endtoend labelling processes including driving labelling strategies for both development programs and established drugs and oversee all operational [. .. ] PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed. Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control. Utilize regulatory/ product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines. Skills and Experience University Degree in a scientific degree. Experienced in the following : CCDS, PIL, USPI, Target label profiles. [. .. ]
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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 209 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:
- Cpl Life Sciences (11 Jobs)
- Veeda Lifesciences (11 Jobs)
- wax. (11 Jobs)
- Bio Talent (11 Jobs)
- IQVIA (9 Jobs)
- S3 Science Recruitment (3 Jobs)
In welchen Bundesländern werden die meisten Drug Regulatory Affairs Jobs angeboten?
Die meisten Stellenanzeigen für Drug Regulatory Affairs Jobs werden derzeit in Nordrhein-Westfalen (32 Jobs), Bayern (26 Jobs) und Niedersachsen (14 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Regulatory Affairs Jobs?
Drug Regulatory Affairs Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
