About Exphar
Exphar is a Belgian company active in Africa for 40 years. Exphar develops and produces generic medicines in India to offer affordable European quality medicines for the African market.
In the frame of an expansion on new markets, Exphar is looking for a Regulatory Affairs officer to lead the registration of Exphar portfolio in Europe.
Role description
Exphar is looking for an experienced Regulatory Affairs (RA) officer to join the Regulatory Affairs team. The RA Officer provides support for the authoring of dossier and coordination of regulatory submissions, implementation and execution of regulatory strategy and health authority interaction, and post-approval life-cycle management with internal and external partners.
- Evaluate the specificities and regulatory requirements of the European markets associated with the submission of Exphar portfolio onto these markets.
- Define the strategy for the registration of new products
- Compile, write and submit the dossiers.
- Manage communications with regulatory authorities.
- Contribute and/or coordinate packaging development.
- Review of product marketing materials to ensure conformity with product claims.
- Monitor and communicate regulatory requirements in EU to ensure preparedness for upcoming submissions.
- Technical Support and Training:
- Provide technical expertise to project teams.
- Conduct training on European regulatory requirements for internal teams
- Provide regular updates on the project’s progress to internal stakeholders.
Your profile
- Advanced degree in life sciences (e.g., veterinary medicine, toxicology, pharmacy, chemistry, etc.) or equivalent.
- Previous experience in Regulatory Affairs (minimum of 5 years)
- Experience in Regulatory registration in EU
- Experience liaising with Health Authorities
- In-depth knowledge of the regulatory environment, guidelines, and practice of EMEA regions
- Experience with generic medicines is an asset.
- Good planning and organizational skills
- Strong interpersonal communication skills (verbal and written).
- English and French required.
Location
The position is located in Nivelles, Brabant Wallon, Belgique (15km south from Bruxelles)
Why join us?
Exphar offers you the opportunity to join a successful pharmaceutical group that cares about patients, a group present in +20 countries in French, English, and Portuguese speaking Africa. By our side, you will develop your skills and share them with us. You will allow us to continue to make quality healthcare accessible to as many people as possible.