International Regulatory Affairs Officer

Overview:

Join a globally recognised pharmaceutical leader that is expanding its regulatory footprint across international markets. This newly created position offers the chance to work at the heart of regulatory operations, shaping the future of product access and compliance in collaboration with cross-functional teams and global affiliates.

You'll be part of a collaborative and expert-driven environment where your input will directly impact strategic regulatory outcomes. The role offers strong development potential and the ability to engage with regulatory authorities and partners across diverse jurisdictions.

Responsibilities:

Drive the preparation and coordination of regulatory submissions, including marketing authorisations, renewals, variations, and labelling updates

Develop submission strategies and regulatory pathways in close collaboration with senior regulatory management

Act as a key point of contact for global affiliates, local partners, and health authorities, ensuring timely and compliant dossier submissions

Draft and review key documents such as product information, SPCs, PILs, and artwork aligned with internal standards and regulatory requirements

Maintain up-to-date knowledge of regional regulatory frameworks and provide expert advice to internal stakeholders

Contribute to the ongoing improvement of internal regulatory processes and participate in department knowledge-sharing initiatives

Experience & Qualifications:

Degree-qualified in Pharmacy, Life Sciences, or a related field; a specialisation in pharmaceutical regulatory affairs or healthcare law is a strong plus. experience working

Solid experience in Regulatory Affairs within the pharmaceutical or life sciences sector

Experience with regulatory procedures at EU and national levels, including Centralised, Decentralised and Mutual Recognition, and National Procedures

Strong communication skills in both French and English are essential

Detail-oriented with a proactive approach and the ability to manage multiple projects in parallel

In Return, you will receive:

Competitive salary and benefits package

Hybrid working model with flexibility

Opportunity to grow within an internationally oriented and collaborative team

A chance to contribute to meaningful healthcare solutions that reach patients worldwide

If you are ready to advance your career and have the skills and ambition for this position, please email your CV to Hattie Davies at or contact (0).

Mots-clés:

Affaires réglementaires, Dossier réglementaire, Soumissions réglementaires, Demandes d'autorisation de mise sur le marché, AMM, Procédure centralisée, Procédure décentralisée, Procédure de reconnaissance mutuelle, Procédure nationale, Résumé des caractéristiques du produit, RCP, Notice, Information produit, Conformité réglementaire, Autorités de santé, EMA, ANSM, AFMPS, France, Belgique, Affaires réglementaires internationales, Industrie pharmaceutique, Sciences de la vie, Réglementation européenne, Gestion du cycle de vie réglementaire, Documentation réglementaire, Réglementation du médicament, Droit pharmaceutique