Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Dunkerque; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading company in the pharmaceutical sector seeks a Senior Consultant in Regulatory Affairs to support clients in developing and managing drug-delivery devices. The role involves leading regulatory strategies, guiding R&D teams, and ensuring compliance with EU and US regulations. Ideal candidates will have extensive experience in regulatory affairs, strong project management skills, and fluency in English, with French being a plus.

Qualifications

• Min 8-12 years in Regulatory Affairs/R&D.
• Experience with drug-delivery devices and combination products.

Responsabilités

• Lead regulatory strategy development for drug-delivery devices.
• Provide guidance on EU and US regulatory pathways.
• Mentor other consultants and contribute to training.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Quality Management Systems

Fluency in English

Fluency in French

Formation

University degree in Biomedical Engineering

Pharmacy

Health Technology

Medical Science

Description du poste

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Client:

Beyond Conception GmbH

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

69177547883020288327668

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

Job Description:

As an RA (Senior) Consultant, you will play a pivotal role in supporting pharmaceutical and medical device clients in the development, submission, and lifecycle management of drug-delivery devices and combination products. You will lead and guide a variety of regulatory projects, providing expert advice on regulatory strategies, classifications, and pathways, while collaborating closely with R&D teams to develop new products or manage the lifecycle of authorized ones. You will be responsible for the end-to-end regulatory support and will contribute significantly to the successful market entry and maintenance of combination products in key regulatory regions, including the EU and US.

Key responsibilities include:

1. Leading and implementing the regulatory strategy development for drug-delivery devices and combination products.
2. Providing guidance on regulatory classification and submission pathways for the EU (MDR, CE Marking) and the US (FDA, 510(k), PMA, NDA, BLA, ANDA).
3. Supporting R&D teams in the development phase, from design control to quality management, ensuring compliance with applicable technical standards and regulatory frameworks.
4. Liaising with key internal stakeholders, including RA CMC, Manufacturing, Clinical Development, and Marketing, to compile dossiers and technical documentation for regulatory submissions.
5. Drafting/reviewing relevant device sections of eCTD modules (e.g., 3.2.R, 3.2.P.2) for combination products applications.
6. Managing communications with notified bodies and health authorities, including participation in audits and inspections.
7. Mentoring other consultants and sharing knowledge within the team, contributing to internal training and development.

Your Profile:

You are an independent and proactive professional with a passion for contributing to cutting-edge regulatory projects. You thrive in dynamic environments and are adept at adjusting to clients' needs while ensuring high-quality regulatory outcomes. You are eager to continually learn and share knowledge with both clients and internal teams, demonstrating a strong commitment to your professional development.

You possess:

• Min 8–12 years of relevant experience in Regulatory Affairs and/or R&D related to:
• Drug-delivery devices (e.g., pre-filled syringes, autoinjectors, dry powder/metered dose inhalers, oral/nasal vaccines, blow-fill seals).
• Combination products under EU (MDR, CE Marking, Notified Body Opinion) and/or US (FDA, 510(k), PMA, NDA, BLA, ANDA) regulatory frameworks.
• Quality Management Systems for medical devices and combination products (ISO 13485, MDR, 21 CFR 820/QSR/QMSR, ISO 14971).
• Solid expertise in the development of devices under design controls and familiarity with technical standards applicable to drug-delivery devices.
• Experience in supporting R&D teams through the development phases of combination products.
• Ability to independently manage projects and stakeholder relationships, leading regulatory strategies for multiple clients in parallel.
• Experience working cross-functionally with RA CMC, Manufacturing, Clinical, and Commercial teams to compile technical documentation and regulatory submissions.
• Proven experience in handling NB/FDA/NCA audits and inspections.
• University degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or another relevant field.
• Fluency in English (required) and French (desired).