Regulatory Affairs Manager - France (French & Belgian Products)

Merck Healthcare · Tunis

New

Senior 🇬🇧 English

Job description

About the role

This regulatory manager position reports to the France Regulatory Affairs Director and covers a portfolio of products. It acts as a strategic partner to business teams and support functions, ensuring regulatory activities comply with French and Belgian regulations.

Key responsibilities

Maintain and optimise the Marketing Authorisation (MA) portfolio
Lead the preparation of variation files, from planning to submission, including local requirements for Module 1
Ensure regulatory compliance of packaging components
Carry out proactive regulatory monitoring and assess the business impact of regulatory changes

Required profile

Master's degree in pharmacy or Life Sciences (Biology, Chemistry or a related field); a Pharmacy degree is a plus
Minimum of 5 years of experience in a similar role
Knowledge of the pharmaceutical or biopharma environment
Fluent French and English, written and spoken

Required skills

Solid expertise in national and European regulations
Solid expertise in regulatory registration processes for pharmaceutical products

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Published 2 hours ago

Expires 1 month from now

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Merck Healthcare

Tunis

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