205 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 [...]
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[...] 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 [...]
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[...] 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 11 Tagen bei Neuvoo.com gefunden
Denk Pharma GmbH Co. KG
Junior Manager (m/w/d) Regulatory Affairs für die Region Afrika
• Munich
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 vor 11 Tagen bei Neuvoo.com gefunden
Denk Pharma GmbH Co. KG
Manager (m/w/d) International Regulatory Affairs
• Munich
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 14 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 [...]
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[...] 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
[. .. ] 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 [...]
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[...] 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 [...]
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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 [...]
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[...] 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
• 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 [...]
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[...] 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 gestern bei Jobleads gefunden
Principal DP (Drug Product) Product Steward-Global MSAT
• Mannheim, Baden- Württemberg
[. .. ] 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 [...]
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[...] 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 [. .. ] as well as process development in the field of biological molecules. Significant cross-functional 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/ patient-centricity as key elements of design and delivery # # # Who we are A healthier future drives us to innovate. Together, more than 100000 employees across the globe are dedicated to advance science, ensuring everyone has access to [. .. ]
Job gestern bei Jobleads gefunden
• Essen, Nordrhein- Westfalen
Medical
Affairs Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
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[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job gestern bei Jobleads gefunden
Associate Director Regulatory Affairs
Führungs-/ Leitungspositionen
This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director
Regulatory Affairs in Switzerland. In this role, you will play [...]
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[...] a key part in shaping and executing regulatory strategies across the EMEA region for innovative therapies addressing rare diseases. You will operate in a dynamic, science-driven environment, working closely with cross-functional teams to support late-stage development, global clinical trials, [. .. ] or a related field; an advanced degree is preferred Minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotech industry Strong knowledge of global regulatory frameworks, drug development processes, and postapproval requirements Proven experience with EMEA regulations, including drugs, biologics, and advanced therapy medicinal products Specific regulatory experience related to the GCC region is required Excellent communication, collaboration, and stakeholder management skills Fluency in English; Arabic is a strong advantage Willingness to travel occasionally, generally less than [. .. ]
Job gestern bei Jobleads gefunden
Medical Affairs Manager
• Düsseldorf, Nordrhein- Westfalen Duesseldorf
Medical
Affairs Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job gestern 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 [...]
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[...] 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 [. .. ]
Job gestern bei Jobleads gefunden
Senior CMC Scientist
• Berlin
We are seeking a Senior CMC Scientist (Biologics) to support late-stage development and lifecycle management of biologic
drug products (e. g. monoclonal antibodies, recombinant proteins, or advanced biologics) . [...]
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[...] This role will play a key part in CMC strategy, regulatory submissions, and technical oversight for EU and global programs. Berlin-based biotech companies typically value handson expertise combined with regulatory awareness, and this role reflects that balance. Key Responsibilities CMC Development Lead and support CMC development activities for biologic drug substances and drug products Act as a CMC subjectmatter expert [. .. ] readiness Review batch records, deviation reports, and change proposals Participate in manufacturing campaigns and troubleshooting activities Cross Functional Collaboration Work closely with : Process Development Analytical Development Quality Assurance Regulatory Affairs Clinical Project Management Represent CMC in project team meetings and governance forums Required Qualifications Experience Education Ph D or MSc in Biotechnology, Biochemistry, Pharmaceutical Sciences, or related field Experience 58+ years experience in CMC development for biologics Strong experience with : Monoclonal antibodies, recombinant proteins, or similar biologics EU regulatory submissions [. .. ]
Job gestern bei Jobleads gefunden
Medical Affairs Manager
• Hamburg
Medical
Affairs Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job gestern 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 [...]
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[...] 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 gestern bei Jobleads gefunden
Medical Affairs Manager
• Leipzig, Sachsen
Medical
Affairs Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job gestern bei Jobleads gefunden
(Associate) Director Market Access (m/f/d) LIVE Portfolio
• München, Bayern
Führungs-/ Leitungspositionen
[. .. ] Description Company Overview Gilead Sciences, Inc. is a researchbased biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] discovery and investigational drug candidate, we seek to improve the care of patients living with lifethreatening diseases around the world. Gileads therapeutic areas of focus include HIV/ AIDS, liver diseases, cancer, inflammation, and serious respiratory conditions. Position Summary Market Access is a strategic function at Gilead, ensuring patients have timely access to our therapies [. .. ] Provide input into clinical development to ensure optimal reimbursement and launch readiness. Design, conduct, and publish HEOR studies, including realworld data (RWD) analyses. Collaborate closely with local Market Access, Medical, Regulatory, Government Public Affairs, and global HEOR and Value Access teams. Qualifications Skills M asters degree in Market Access/ Health Economics, N ature or E conomic S cience or M edical D egree Minimum 7 years of experience in Market Access within pharma, biotech, or healthcare Deep understanding of German healthcare system and AMNOG [. .. ]
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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 205 offene Stellenanzeigen für Drug Regulatory Affairs Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Drug Regulatory Affairs Jobs?
Aktuell suchen 18 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 (10 Jobs)
- Denk Pharma GmbH Co. KG (2 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 (34 Jobs), Bayern (23 Jobs) und Sachsen (19 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Regulatory Affairs Jobs?
Drug Regulatory Affairs Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
