Responsable Affaires Réglementaires - spécialiste produits combinés

JR France; Puteaux; À distance; EUR 80 000 - 100 000; Plein temps

Résumé du poste

A leading company in regulatory affairs is seeking a Senior Consultant to support pharmaceutical clients in the lifecycle management of drug-delivery devices. This role involves leading regulatory strategy, guiding projects, and collaborating with R&D teams. The ideal candidate will have extensive experience in regulatory frameworks and a strong commitment to professional development. This is a virtual position requiring a proactive and independent professional.

Qualifications

• 8–12 years of experience in Regulatory Affairs and/or R&D.
• Experience with EU and/or US regulatory frameworks.

Responsabilités

• Lead regulatory strategy development for drug-delivery devices.
• Manage communications with notified bodies and health authorities.
• Mentor other consultants and contribute to internal 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

Client:

Beyond Conception GmbH

Location:

Virtual job fairs

Job Category:

Other

EU work permit required:

Yes

Job Reference:

69177547883020288327671

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.

Qualifications include:

• 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).
• Experience with EU (MDR, CE Marking, Notified Body Opinion) and/or US (FDA, 510(k), PMA, NDA, BLA, ANDA) regulatory frameworks for combination products.
• Knowledge of Quality Management Systems for medical devices and combination products (ISO 13485, MDR, 21 CFR 820/QSR/QMSR, ISO 14971).
• Solid expertise in device development under design controls and familiarity with technical standards for drug-delivery devices.
• Experience supporting R&D teams through development phases of combination products.
• Ability to independently manage projects and stakeholder relationships, leading regulatory strategies for multiple clients simultaneously.
• Experience working cross-functionally with RA CMC, Manufacturing, Clinical, and Commercial teams.
• Proven experience handling NB/FDA/NCA audits and inspections.
• University degree in Biomedical Engineering, Pharmacy, Health Technology, Medical Science, or relevant field.
• Fluency in English (required) and French (desired).

Additional notes:

This is a virtual position. Please note that if you are not a passport holder of the country for the vacancy, you might need a work permit. For more information, check our Blog.

Bank or payment details should not be provided when applying. All applications should be made via the 'Apply now' button.