Responsable Affaires Réglementaires - spécialiste produits combinés

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

Résumé du poste

A leading company in the pharmaceutical sector is seeking a Senior Regulatory Affairs Consultant to support clients in the development and management of drug-delivery devices. The role involves leading regulatory projects, ensuring compliance with EU and US regulations, and mentoring team members. Ideal candidates will have significant experience in Regulatory Affairs, strong project management skills, and a commitment to high-quality outcomes.

Qualifications

• 8–12 years of experience in Regulatory Affairs and R&D for drug-delivery devices.
• Experience with Quality Management Systems for medical devices.

Responsabilités

• Lead regulatory strategy development for drug-delivery devices.
• Provide guidance on EU and US regulatory pathways.
• Manage communications with notified bodies and health authorities.

Connaissances

Regulatory Affairs

Project Management

Stakeholder Management

Quality Management Systems

Fluency in English

Formation

University degree in Biomedical Engineering

University degree in Pharmacy

Description du poste

Job Description:

As a Senior Regulatory Affairs (RA) 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 strategies, classifications, and pathways, while collaborating closely with R&D teams to develop new products or manage existing ones. Your responsibilities include ensuring successful market entry and maintenance of products in key regions such as 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 during development, from design control to quality management, ensuring compliance with standards.
4. Liaising with internal stakeholders to compile dossiers and documentation for 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 team members and contributing to internal training and development.

Your Profile:

You are an independent, proactive professional passionate about regulatory projects, thriving in dynamic environments, and committed to high-quality outcomes. You are eager to learn and share knowledge, with a strong focus on professional development.

You possess:

• 8–12 years of relevant experience in Regulatory Affairs and 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.
• Expertise in device development under design controls and technical standards.
• Ability to manage projects and stakeholder relationships independently.
• Cross-functional experience 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 a plus.