Regulatory Affairs Officer (M/F)
Machine translation — original language: French.Show original
About the company
Fed Engineering, a recruitment firm dedicated to industrial functions, is recruiting for its client, a Regulatory Affairs Officer (Pharmacist) M/F, as part of a 6-month replacement.
Your tasks
Reporting to the department manager, you will take charge of your range of medicines and ensure regulatory compliance. In this capacity, you will:
- Manage your regulatory activities related to marketing authorizations (AMM): registration and maintenance,
- Prepare AMM modification requests,
- Follow up on all variation requests until approval,
- Respond to inquiries from health authorities,
- Submit AMM requests,
- Update the database,
- Ensure weekly regulatory monitoring,
- Prepare and validate packaging articles to launch new products,
- Participate in meetings,
Requirements
With a 'pharmacist regulatory affairs' background, you have 4 years of experience in a similar position.
You are proficient in the compilation and electronic submission of AMM dossiers and your English must be fluent.
What we offer
Remuneration: €38 to €44 K gross/year (fixed according to experience) + meal vouchers + CSE benefits + remote work possible.