About exphar :
Exphar is a Belgian company that has been active in Africa for 40 years. We develop and produce generic medicines in India to offer high-quality medications at affordable prices for the African market.
As part of a maternity leave replacement, we are looking for a Regulatory Affairs Officer to manage the registration of our product portfolio.
Job description :
Exphar is looking to add an experienced Regulatory Affairs (RA) Officer to its team.
You will support the preparation of regulatory dossiers, coordinate regulatory submissions, implement regulatory strategies, interact with health authorities, and manage the post-approval lifecycle alongside our internal and external partners.
We offer a full-time temporary contract for 6 to 9 months to cover a maternity leave.
We are looking for someone available to start in June 2025.
Main responsibilities :
Assess the specific regulatory requirements of the markets targeted by Exphar.
Define the registration strategy for new products.
Compile and write regulatory dossiers.
Manage communications with regulatory authorities.
Contribute to the development and coordination of packaging materials.
Review marketing materials to ensure compliance with product claims.
Conduct regulatory intelligence and communicate updates to internal teams.
Provide regular updates on project progress.
Your profile :
Higher education degree in life sciences (pharmacy, chemistry, veterinary medicine, toxicology, etc.) or equivalent.
At least 1 year of experience in writing regulatory affairs dossiers.
Experience in communicating with health authorities.
In-depth knowledge of regulatory frameworks and current guidelines.
Experience with generic medicines is an asset.
Strong organizational and planning skills.
Excellent oral and written communication skills.
Perfect command of French and English is essential (daily communication with international stakeholders).
Location :
Position based in Nivelles, Walloon Brabant, Belgium.
Why join us ?
Exphar offers you the opportunity to join a successful pharmaceutical group committed to improving patient health in over 20 countries across Francophone, Anglophone, and Lusophone Africa.
By joining our team, you will develop your skills and actively contribute to our mission: making quality healthcare accessible to as many people as possible.