Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Issy-les-Moulineaux; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Senior Consultant in Regulatory Affairs to lead projects related to drug-delivery devices. The role involves strategic guidance, compliance management, and collaboration with R&D teams to ensure successful market entry of products. Ideal candidates will have extensive experience in regulatory frameworks and a strong commitment to professional development.

Qualifications

• Min 8–12 years of experience in Regulatory Affairs and/or R&D.
• Experience with Quality Management Systems for medical devices.

Responsabilités

• Leading regulatory strategy development for drug-delivery devices.
• Providing guidance on regulatory classification and submission pathways.
• Supporting R&D teams ensuring compliance with applicable standards.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Quality Management

Formation

University degree in Biomedical Engineering

Pharmacy

Description du poste

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Client:

Beyond Conception GmbH

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

69177547883020288327620

Job Views:

1

Posted:

15.05.2025

Expiry Date:

29.06.2025

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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 various 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 end-to-end regulatory support, contributing significantly to the successful market entry and maintenance of combination products in key regions, including the EU and US.

Key responsibilities include:

1. Leading and implementing 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 standards and frameworks.
4. Liaising with internal stakeholders to compile dossiers and technical documentation for regulatory submissions.
5. Drafting and reviewing device sections of eCTD modules for applications.
6. Managing communications with notified bodies and health authorities, including 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 passionate about regulatory projects. You thrive in dynamic environments, adjusting to client needs while ensuring high-quality outcomes. You are eager to learn and share knowledge, demonstrating a strong commitment to professional development.

Qualifications include:

• Min 8–12 years of experience in Regulatory Affairs and/or R&D related to drug-delivery devices and combination products under EU and US frameworks.
• Experience with Quality Management Systems for medical devices and combination products.
• Solid expertise in device development under design controls and technical standards.
• Experience supporting R&D teams during development phases.
• Ability to independently manage projects and stakeholder relationships.
• Experience working cross-functionally with RA CMC, Manufacturing, Clinical, and Commercial teams.
• Proven experience in handling audits and inspections.
• University degree in Biomedical Engineering, Pharmacy, or related fields.
• Fluency in English; French is desired.