Responsable affaires réglementaires - spécialiste produits combinés

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:


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