Regulatory Affairs Officer – Pharmacist (Remote, Belgium)

About the role

RA Consultancy BV is seeking a qualified pharmacist to join its team as a Regulatory Affairs Officer. The position is fully remote and can be undertaken on a part‑time or full‑time basis, but the candidate must be based in Belgium. Entry‑level and junior professionals are encouraged to apply.

Key responsibilities

• Prepare, review and maintain regulatory documentation for medicinal products in accordance with Benelux and EU requirements.
• Coordinate and submit regulatory applications, variations, renewals and responses to health‑authority queries.
• Monitor regulatory updates, interpret new guidelines and communicate their impact to internal and external stakeholders.
• Support Quality Assurance, Medical Affairs and Pharmacovigilance teams with regulatory aspects.
• Maintain regulatory databases and tracking tools throughout the product lifecycle.
• Collaborate with clients and authorities to ensure continuous compliance.

Required profile

• Currently residing in Belgium.
• Qualified pharmacist (MSc in Drug Development or MSc in Pharmaceutical Care).
• Fluent in Dutch and English; French is a plus.
• Strong knowledge of EU and Benelux regulatory frameworks.
• Entry‑level or junior experience in regulatory affairs is welcomed.

Required skills

• Experience with regulatory documentation preparation and lifecycle maintenance.
• Familiarity with regulatory submissions (applications, variations, renewals).
• Ability to interpret regulatory guidelines and legislation.

What we offer

• Fully remote work arrangement.
• Flexibility to choose part‑time or full‑time hours.
• Opportunity to work with a specialized consultancy serving the Benelux and EU pharmaceutical market.