Job Description
Blackfield Associates are supporting our client, a well-established generic and innovation pharmaceutical company based in Slough, in the search for a Regulatory Affairs Manager to join their expanding team. This is an exciting opportunity for a regulatory professional to play a pivotal role in the preparation, review, and strategic assessment of regulatory submissions across EU markets, particularly under the centralised procedure.
As Regulatory Affairs Manager, you will be responsible for:
1. Review and Authoring of Modules 1–5 of regulatory dossiers in alignment with EMA and ICH requirements.
2. Lead the preparation and submission of marketing authorisation applications via the Centralised Procedure
3. Conduct independent due diligence assessments for in-licensing or acquisition of new product dossiers – including new chemical entities (NCEs) and generics.
4. Perform detailed evaluations of Phase III clinical study data and CMC sections of dossiers, identifying regulatory risks and mitigation strategies.
5. Provide strategic regulatory guidance to cross-functional teams during product development, submission planning, and lifecycle management.
6. Maintain up-to-date knowledge of EU regulatory requirements and changes in legislation impacting product development and marketing authorisation.
7. Liaise with external partners, consultants, and Health Autho...