Regulatory Affairs Manager - Pharmaceutical Sector (M/F)
Machine translation — original language: French.Show original
JOB DESCRIPTION
Reporting to the Global Director of Regulatory Affairs and CMC, your missions are:
- Act as the CMC regulatory affairs referent for a portfolio of pharmaceutical products (small molecules and biomolecules/ADCs), supporting internal teams and clients
- Define and drive CMC regulatory strategies throughout the product lifecycle, from preclinical to commercialization
- Guarantee regulatory compliance by contributing to the implementation and improvement of internal standards in line with international requirements
- Perform gap analyses, drive associated action plans, and support teams in product development
- Supervise the preparation, review, and submission of regulatory dossiers (CMC modules), as well as the follow-up of exchanges with health authorities
- Contribute to change management, team training, and the strengthening of cross-functional collaboration between Drug Substance and Drug Product activities
- Manage one person in regulatory affairs at the Saint Beauzire site
You will travel up to 10% to the headquarters in Switzerland (5 weeks per year)
Why join this company?
- Join a company working for patient well-being by developing medicines in complex sectors (oncology or other rare diseases).
- In strong growth, the French site has grown from 35 employees in 2019 to 160 in 2025 and aims to continue this strong growth
- Join a position with a strong international context and cross-functional interactions within the group
- Social benefits: Pharmaceutical industry collective agreement, €9 meal vouchers covered at 60%, attractive CSE
REQUIRED PROFILE
- You hold a Master's degree / Engineer / PhD in biochemistry, chemistry, or pharmacy
- You have at least 7 years of experience in a pharmaceutical field
- You have experience in CMC
- You have mastered GMP/BPF regulations, ICH guidelines, Ph.Eur/USP, and Eudralex (particularly volumes 4 and 10),
- You are able to communicate in English, both written and oral.
ADDITIONAL INFORMATION
- Location: Saint-Beauzire
- Contract: CDI – Executive (Cadre)
- Salary: Up to €75K fixed over 12 months
If your profile matches, we will get back to you within 7 days of the submission date.