Regulatory Affairs CMC Specialist
Overview
We are looking for an experienced Regulatory Affairs CMC Specialist to support the management of Marketing Authorisations (MAs) across EU and international markets. The role focuses on CMC-related submissions, regulatory compliance, and collaboration with health authorities, partners, and internal teams.
Responsibilities
- Prepare and submit Marketing Authorisation Applications, variations, renewals, and other lifecycle documents.
- Manage regulatory authority interactions, including responses to queries.
- Compile and publish dossiers using validated systems in correct electronic formats.
- Ensure alignment between authorised MAs and manufacturing site procedures.
- Review CMC-related changes (quality, manufacturing, supply chain, CMOs).
- Approve product artwork for compliance.
- Support activities with corporate teams, licensing partners, and local health authorities.
- Review GMP documentation (e.g., batch records, specifications, analytical methods).
- Maintain regulatory status databases and circulate approval updates.
Requirements
- Degree in Pharmacy, Chemistry, Life Sciences, or related discipline.
- 5+ years' experience in Regulatory Affairs, with a focus on CMC.
- Strong knowledge of EU regulations, EMA guidelines, and MAA preparation.
- Familiarity with GMP and pharmaceutical quality systems.
- Skilled in electronic document management/publishing.
- Excellent attention to detail, organisation, and communication skills.
