250 Jobs für Regulatory Agency
Stellenangebote Regulatory Agency Jobs
Job vor 7 Tagen bei StepStone gefunden
Lohmann Animal Health/ Elanco
• Cuxhaven
Führungs-/ Leitungspositionen
[. .. ] D or other sites to Cuxhaven, building strong cross-functional partnerships, and ensuring technical readiness for new product launches. Quality, Regulatory Compliance: Serve as a primary participant and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] SME during regulatory agency audits, actively leading site-wide quality improvement initiatives, and overseeing the technical accuracy of regulatory submissions. Organizational People Development: Direct and mentor a high-performing team of scientists and engineers, fostering a culture of continuous process optimization and innovation, and setting clear performance objectives aligned with site and global strategies. [. .. ]
Job am 05.05.2026 bei Jobleads gefunden
Clinical Trials Lead Site Coordinator
• Zug
Führungs-/ Leitungspositionen
[. .. ] and Site payments and processes as needed. Schedule and/or perform study procedures as per study requirements and delegation of responsibilities. Prepare for and participate in onsite study [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] audits or regulatory agency inspections. Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions) . Qualifications College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics. Minimum of 2 years of on-the-job experience in a clinical trial environment, where relevant experience has [. .. ]
Neu Job vor 3 Std. bei Jobleads gefunden
[. .. ] S. and international dossiers. Partner closely with Regulatory Affairs CMC Project Leads to develop Module 3 content and overall submission strategies. Coordinate the preparation of submission documents [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and responses to regulatory agency inquiries, working with subject matter experts across functions. Serve as the project manager for assigned regulatory initiatives, driving timelines, deliverables, and stakeholder accountability. Interface with subject matter experts in R D, Manufacturing, Process Development, Analytical Sciences, Quality, and other technical groups to gather information and resolve issues. Independently facilitate project [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Global Regulatory Project Lead-Global Regulatory Affairs
• Monheim, Bayern
[. .. ] submission plans, review project-related communications, and generate and review policies, SOPs, and guidance to ensure compliance. Meeting Leadership: Lead team meetings regarding Quality, Safety, and Effectiveness technical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] sections during regulatory agency interactions, or support team members as needed. Policy Ethics: Comply with all company local and global policies, including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and HSE standards. Minimum Qualifications Education: Masters degree or higher in Veterinary Medicine, Biology, Infectious Diseases, Immunology, or a related field. Experience: Minimum 10 [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
• Zug
Führungs-/ Leitungspositionen
[. .. ] Design (Qb D) and Quality Risk Management principles Proven track record managing CDMOs and external development/ manufacturing partnerships Strong understanding of global regulatory requirements, including CTA and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] NDA submissions Experience supporting regulatory agency interactions Eligible to work in Switzerland and the EU. #J-18808-Ljbffr 97389463 [. .. ]
Job vor 7 Tagen bei Jobleads gefunden
Senior CMO Quality Assurance Manager
• Waldstetten, Baden- Württemberg
Führungs-/ Leitungspositionen
[. .. ] technical visits, facilitating periodic meetings, supporting Quality Audits, and collaborating with Supply Chain, CMO Management, and Regulatory Affairs. Managing all quality-related requirements for CMO Management, you will [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] assist with regulatory agency interactions (e. g. , FDA, EMA) , recommend product release/ rejection, and advise on halting production to ensure compliance and quality. Acting as a key interface for the quality team, you will manage multiple parallel topics with conflicting priorities while collaborating with various internal and external stakeholders. Accountable to be [. .. ]
Job vor 8 Tagen bei Jobleads gefunden
• Monheim, Bayern
Führungs-/ Leitungspositionen
[. .. ] innovation projects, with direct ownership for EU and USA regulatory activities. Drive preapproval and developmentdriven lifecycle management activities, including clinical trial submission plans and Quality, Safety, and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Effectiveness content for regulatory agency interactions. Partner with crossfunctional teams to assess regulatory impact on product development, target label, registration strategy, timelines, and resource needs. Lead engagement with regulatory agencies in the EU or USA and coordinate with regional and local regulatory leaders to support approvals in additional firstwave countries aligned to the global strategy. [. .. ]
Job vor 8 Tagen bei Jobleads gefunden
Associate Director, Regulatory Affairs, EU RoW
• Sankt Gallen
Führungs-/ Leitungspositionen
[. .. ] or biotechnology industry or government health agency, including demonstrated leadership of complex development programs and strategic interactions with major health authorities. Demonstrated track record of successful approvals [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] from a major regulatory agency is required. Prior regulatory agency liaison experience is essential. Solid expertise and knowledge of the drug development process is required. Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions. Experience in interpretation and application of ICH and [. .. ]
Job vor 8 Tagen bei Jobleads gefunden
Sr. Director, Pharmaceutical Technical Services/ Manufacturing Science (m/f/d) - Pharma
• Cuxhaven, Niedersachsen
Führungs-/ Leitungspositionen
[. .. ] D or other sites to Cuxhaven, building strong cross-functional partnerships, and ensuring technical readiness for new product launches. Quality, Regulatory Compliance: Serve as a primary participant and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] SME during regulatory agency audits, actively leading site-wide quality improvement initiatives, and overseeing the technical accuracy of regulatory submissions. Organizational People Development: Direct and mentor a high-performing team of scientists and engineers, fostering a culture of continuous process optimization and innovation, and setting clear performance objectives aligned with site and global strategies. [. .. ]
Job vor 12 Tagen bei Jobleads gefunden
Global Regulatory Project Lead-Global Regulatory Affairs
• Monheim, Bayern
[. .. ] the generation and review of policies, SOPs, and guidance to ensure compliance with national competent authority regulations. Meeting Leadership Lead team meetings regarding Quality, Safety, and Effectiveness [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] technical sections during regulatory agency interactions, or support team members in these activities as required. Policy Ethics Comply with all company local and global policies, including quality frameworks, Code of Conduct, antidiscrimination, harassment, and Health, Safety, and Environment (HSE) standards. Required Qualifications Education Masters degree or higher in Veterinary Medicine, Biology, Infectious Diseases, Immunology, or [. .. ]
Job vor 12 Tagen bei Jobleads gefunden
• Rapperswil- Jona, Sankt Gallen
Führungs-/ Leitungspositionen
[. .. ] pharmaceutical or biotechnology industry or a government health agency, with demonstrated leadership of complex programs and strategic interactions with major health authorities. Track record of successful approvals [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] from a major regulatory agency required; prior regulatory agency liaison experience essential. Solid expertise in the drug development process. Ability to apply scientific principles to assess regulatory issues and draw valid conclusions. Experience interpreting and applying ICH and EU guidelines relevant to product development and submission of pre/ postauthorization applications. Extensive track record in drafting [. .. ]
Job vor 12 Tagen bei Jobleads gefunden
Principal (European Competition practice) - m/f/d
• München, Düsseldorf, Bayern, Nordrhein- Westfalen
[. .. ] to the facts of each case, employing tools such as merger simulation, upward pricing pressure analysis, econometrics, bargaining theory, or game theory as needed. Whether before a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] court or a regulatory agency, CRA consultants set a high standard for the clear communication of sophisticated economic analysis in complex cases. You will have access to internal training programs focused on creative problem solving, communications, and leading and managing colleagues, teams and cases. In addition, our firm offers extracurricular activities where you can take [. .. ]
Job vor 13 Tagen bei Jobleads gefunden
• Zürich
[. .. ] participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e. g. ICH) . Maintains well organized, complete, and up-to-date project documentation, and verification/ quality control documents and programs; [. .. ]
Job am 21.06.2026 bei Jobleads gefunden
Sr/ Principal Statistician (Sponsor-dedicated) Many possible locations (EMEA)
• Aargau
[. .. ] participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e. g. , ICH) . Maintains well organized, complete, and up-to-date project documentation, and verification/ quality control documents and [. .. ]
Job am 19.06.2026 bei Jobleads gefunden
Director Drug Product
• Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] Design (Qb D) and Quality Risk Management principles Proven track record managing CDMOs and external development/ manufacturing partnerships Strong understanding of global regulatory requirements, including CTA and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] NDA submissions Experience supporting regulatory agency interactions Please only apply if you are eligible to work in Switzerland and the EU headcount AG #J-18808-Ljbffr 95882904 [. .. ]
Job am 13.06.2026 bei Jobleads gefunden
Senior Principal Engineer, Human Factors
• Bern
[. .. ] selection and oversight of CROs Leverage existing data to support regulatory submissions, e. g. , comparative analysis Develop dossier submissions for HF content, including HFE/ UE Report, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and responses to regulatory agency questions Monitor industry trends, standards, and regulatory guidance Qualifications Excellent communication skills and a track record working in a matrix environment Ability to influence and promote a culture of continuous improvement Subject Matter Expertise on: IEC 62366 family of standards and related regulatory guidance User Capabilities anthropometric basis Use Risk [. .. ]
Job am 12.06.2026 bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] Quality incidents. Drive initiation and execution of market actions, if required. Regulatory and Gx P Compliance: Ensure that the Escalation and Notification to Management related activities and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] documentation meet the relevant regulatory agency and other relevant requirements for the industry (FDA, EMA, any local regulations, ISO, WHO) ; prepare for and support inspections and audits. Training Communication: Develop and deliver training on incident management procedures, share lessons learned from managed Gx P/ Quality incidents and promote a culture of quality and accountability across the [. .. ]
Job am 12.06.2026 bei Jobleads gefunden
Principal Statistician Oncology with Submission Experience
• Zürich
[. .. ] for others opinions. Verify and conduct quality control of project deliverables, ensuring outputs meet SAP and specifications. Lead complex or multiple projects (e. g. , submissions, integrated [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] analyses) , attend regulatory agency meetings or respond to questions to support statistical results of clinical trials. Manage scheduling and time constraints across multiple projects, set goals based on management priorities, and communicate difficulties with meeting timelines. Monitor progress on study activities against milestones and ensure deliverables are met; identify outofscope tasks and report to [. .. ]
Job am 05.06.2026 bei Jobleads gefunden
• Aargau
[. .. ] meets the expected results and is consistent with analysis described in the SAP and specifications. May lead complex or multiple projects (e. g. , submissions, integrated analyses) [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] , and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to [. .. ]
Job am 03.06.2026 bei Jobleads gefunden
Director, Computational Pathology Biomarker Lead (Oncology/ Bio Pharma) (m/f/d)
• München, Bayern
Führungs-/ Leitungspositionen
[. .. ] through AI innovation and successful biomarker implementation. Desirable Demonstrated experience with analytical and clinical validation of AI-enabled biomarker assays for regulatory submissions, companion diagnostics development, and clinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] operationalization, including regulatory agency interactions. Experience developing innovative biomarker strategies including trial enrichment approaches, quantitative composite scores for organ pathology, and alternative endpoints that accelerate clinical timelines. Strong publication record in high-quality scientific journals showcasing AI innovation and biomarker implementation, with active contributions to the research community through conferences, open-source code projects, [. .. ]
Job am 02.06.2026 bei Jobleads gefunden
Director, Team Lead, Computational Pathology Biomarker Development (Oncology/ Bio Pharmaceuticals. . .
• München, Bayern
Führungs-/ Leitungspositionen
[. .. ] through AI innovation and successful biomarker implementation. Desirable Demonstrated experience with analytical and clinical validation of AI-enabled biomarker assays for regulatory submissions, companion diagnostics development, and clinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] operationalization, including regulatory agency interactions. Experience developing innovative biomarker strategies including trial enrichment approaches, quantitative composite scores for organ pathology, and alternative endpoints that accelerate clinical timelines. Strong publication record in high-quality scientific journals showcasing AI innovation and biomarker implementation, with active contributions to the research community through conferences, open-source code projects, [. .. ]
Job am 28.05.2026 bei Jobleads gefunden
Associate Director, Quality Assurance GMP
• Schachen, Appenzell Ausserrhoden
Führungs-/ Leitungspositionen
[. .. ] procedures and current regulations, overseeing SOP review and updates. Manage review and approval of GMP documentation for regulatory filings, clinical supply, development, technology transfer, and equipment qualification. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Coordinate and accompany regulatory agency inspections, facilitate audits, and draft responses to inspection observations. Advise on GMP compliance aspects of facility design, equipment selection, and departmental SOPs. Represent Quality in internal or external manufacturing programs, overseeing batch record review, deviation and change management approvals. Manage all activities within resource constraints while complying with company policies [. .. ]
Job am 27.05.2026 bei Jobleads gefunden
Associate Director Quality Assurance (m/f/d)
• Schachen, Appenzell Ausserrhoden
Führungs-/ Leitungspositionen
[. .. ] procedures and current regulations, overseeing SOP review and updates. Manage review and approval of GMP documentation for regulatory filings, clinical supply, development, technology transfer, and equipment qualification. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Coordinate and accompany regulatory agency inspections, facilitate audits, and draft responses to inspection observations. Advise on GMP compliance aspects of facility design, equipment selection, and departmental SOPs. Represent Quality in internal or external manufacturing programs, overseeing batch record review, deviation and change management approvals. Manage all activities within resource constraints while complying with company policies [. .. ]
Job am 26.05.2026 bei Jobleads gefunden
Director, Computational Pathology Biomarker Lead (Oncology/ Bio Pharma) (m/f/d)
• München, Bayern
Führungs-/ Leitungspositionen
[. .. ] through AI innovation and successful biomarker implementation. Desirable Demonstrated experience with analytical and clinical validation of AI-enabled biomarker assays for regulatory submissions, companion diagnostics development, and clinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] operationalization, including regulatory agency interactions. Experience developing innovative biomarker strategies including trial enrichment approaches, quantitative composite scores for organ pathology, and alternative endpoints that accelerate clinical timelines. Strong publication record in high-quality scientific journals showcasing AI innovation and biomarker implementation, with active contributions to the research community through conferences, open-source code projects, [. .. ]
Job am 22.05.2026 bei Jobleads gefunden
Senior Medical Director, Global Risk Management Safety Surveillance
• Morges, Waadt
Führungs-/ Leitungspositionen
[. .. ] to productrelated queries as delegated by the EU/ UK QPPV. Requirements Medical degree (M. D. ) or equivalent international qualification. Several years of experience in the pharmaceutical/ [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] biotechnology industry or regulatory agency, with significant experience in pharmacovigilance or risk management roles. Indepth knowledge of global risk management/ GVP landscape, with a focus on US/ EU regions. Experience interacting with regulators on risk management issues. Experience as an active contributor with drug registrations (Clinical Study Reports, Integrated Summaries of Safety, Summaries of Clinical [. .. ]
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Häufig gestellte Fragen
Wieviele offene Stellenangebote gibt es für Regulatory Agency Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 250 offene Stellenanzeigen für Regulatory Agency Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Regulatory Agency Jobs?
Aktuell suchen 56 Unternehmen nach Bewerbern für Regulatory Agency Jobs.
Welche Unternehmen suchen nach Bewerbern für Regulatory Agency Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Regulatory Agency Stellenangebote:
- Eumetsat (8 Jobs)
- Turner Townsend (7 Jobs)
- Allianz Global Corporate Specialty SE (6 Jobs)
- Clarios Germany GmbH Co. KG (4 Jobs)
- Allianz Global Investors GmbH (4 Jobs)
- Barclay Simpson (3 Jobs)
In welchen Bundesländern werden die meisten Regulatory Agency Jobs angeboten?
Die meisten Stellenanzeigen für Regulatory Agency Jobs werden derzeit in Bayern (39 Jobs), Sachsen-Anhalt (26 Jobs) und Hessen (25 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Agency Jobs?
Regulatory Agency Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
