275 Jobs für Regulatory Agency
Stellenangebote Regulatory Agency Jobs
Job gestern bei Jooble gefunden
mbiomics GmbH
• München
[. .. ] in alignment with target product profiles (TPPs) , accounting for activities distributed across internal teams and the external partner network. Collaborate with Regulatory and CMC to prepare [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] for and support regulatory agency interactions, including pre-IND, Type B, and scientific advice meetings, as well as INDs/ IMPDs. Ensure development activities are conducted in compliance with applicable Gx P, ICH, and FDA/ EMA guidelines for biologics and microbiome-based therapies, whether executed internally or at external sites. Team External Partner Management Directly manage or [. .. ]
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 [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
• München, Bayern
[. .. ] 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 vor 3 Tagen 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 vor 3 Tagen bei Jobleads gefunden
Sr/ Principal Statistician (Sponsor-dedicated) Many possible locations (EMEA)
• München, Bayern
[. .. ] 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 vor 4 Tagen bei Jobleads gefunden
Accounting and Regulatory Reporting Manager (Canada)
[. .. ] of contact for regulatory inquiries, examinations, and ad hoc information requests. Qualifications 6+ years of experience in regulatory reporting or finance at a bank, fintech, securities dealer, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] investment dealer, financial regulatory agency, or professional services firm serving financial institution clients, with at least 3 years in a regulated entity preparing or reviewing filings for a securities regulator (e. g. , OSC, CIRO/ IIROC) . CPA designation (or equivalent) with deep, handson knowledge of IFRS and Canadian securities regulatory reporting requirements, including NI [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
• 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 vor 7 Tagen bei Jobleads gefunden
Associate Director, EUCAN Regulatory Lead-Oncology
• Zürich Zuerich
Führungs-/ Leitungspositionen
[. .. ] as needed Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross functional Teams; companys consultants and Business Partners as required. Proactively builds/ [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] strengthens external stakeholder (Regulatory Agency where applicable, external experts, industry organizations, etc. ) contacts/ influence to achieve Takeda strategic goals and objectives Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility Leads and manages meetings and/or [. .. ]
Job vor 11 Tagen bei Jobleads gefunden
• 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 vor 12 Tagen bei Jobleads gefunden
Principal/ Senior Scientist: Technical Lead, Drug Substance Drug Product Development
• München, Bayern
[. .. ] in alignment with target product profiles (TPPs) , accounting for activities distributed across internal teams and the external partner network. Collaborate with Regulatory and CMC to prepare [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] for and support regulatory agency interactions, including pre-IND, Type B, and scientific advice meetings, as well as INDs/ IMPDs. Ensure development activities are conducted in compliance with applicable Gx P, ICH, and FDA/ EMA guidelines for biologics and microbiome-based therapies, whether executed internally or at external sites. Team External Partner Management Directly manage or [. .. ]
Job vor 12 Tagen bei Jobleads gefunden
• 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 vor 12 Tagen bei Jobleads gefunden
Principal Statistician Oncology with Submission Experience
• München, Bayern
[. .. ] 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 vor 12 Tagen 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 07.06.2026 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 Experience with user capabilities anthropometric basis [. .. ]
Job am 05.06.2026 bei Jobleads gefunden
Principal Statistician Oncology with Submission Experience
• 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 05.06.2026 bei Jobleads gefunden
Principal Statistician Oncology with Submission Experience
• München, Bayern
[. .. ] 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
• 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
• 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 [. .. ]
Job am 12.05.2026 bei Jobleads gefunden
Legal Counsel, Europe
Homeoffice möglich
[. .. ] and engaging with external legal advisers. Who You Are (Must-Haves) A qualified lawyer (solicitor or barrister) with 35+ years of experience at a law firm, financial institution, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] financial services regulatory agency, exchange, brokerdealer, or technology company. Excellent academic background with a strong foundation in legal analysis and reasoning. Excellent oral and written communication skills with the ability to outline complex matters in a simple, logical, and concise manner. Excellent judgment, analytical rigor, and clear communication skills. Demonstrated ability to own projects [. .. ]
Job am 12.05.2026 bei Jobleads gefunden
Supplier Quality Specialist (Supplier Quality Systems)
• München, Bayern
[. .. ] technical and contractual requirements. Documents and reports audit and assessment results. Inspects or verifies products for compliance with requirements of various technologies and commodities. Performs development part [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] conformity inspections. Supports regulatory agency audits (FAA) . Ensures supplier notifications of quality escapes are processed as required; evaluates supplier Root Cause Analysis and proposed corrective action plans. Assists with assessments of supplier capability and capacity to perform current or potential future work. Provides supplier education and coaching on quality systems, technical expertise, regulatory compliance [. .. ]
Job am 23.04.2026 bei Jobleads gefunden
Senior Director, Regulatory Affairs-Oncology Strategy (Remote)
Führungs-/ Leitungspositionen
[. .. ] development and implementation of strategic and tactical plans in alignment with corporate objectives. Proactively identify and assess regulatory risks associated with product development for Pliants oncology program. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Serve as the regulatory agency contact (e. g. FDA and other agencies) and in this capacity, fosters strong agency relationships while acting as a credible, reputable, and effective advocate for the company. Effectively lead meetings with Health Authorities to ensure full resolution of issues and opportunities. Lead all interactions/ submissions to global Health Authorities including [. .. ]
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Häufig gestellte Fragen
Wieviele offene Stellenangebote gibt es für Regulatory Agency Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 275 offene Stellenanzeigen für Regulatory Agency Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Regulatory Agency Jobs?
Aktuell suchen 66 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)
- Allianz Global Investors GmbH (8 Jobs)
- Digisourced. (7 Jobs)
- Turner Townsend (6 Jobs)
- Propelis (5 Jobs)
- Clarios Germany GmbH Co. KG (4 Jobs)
In welchen Bundesländern werden die meisten Regulatory Agency Jobs angeboten?
Die meisten Stellenanzeigen für Regulatory Agency Jobs werden derzeit in Bayern (34 Jobs), Hessen (31 Jobs) und Sachsen-Anhalt (30 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Agency Jobs?
Regulatory Agency Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
