Regulatory Affairs Manager
Blackfield Associates
Slough, GB
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: Review and Authoring of Modules 1 5 of regulatory dossiers in alignment with EMA and ICH requirements. Lead the preparation and submission of marketing authorisation applications via the Centralised Procedure Conduct independent due diligence assessments for in-licensing or acquisition of new product dossiers including new chemical entities (NCEs) and generics. Perform detailed evaluations of Phase III clinical study data and CMC sections of dossiers, identifying regulatory risks and mitigation strategies. Provide strategic regulatory guidance to cross-functional teams during product development, submission planning, and lifecycle management. Maintain up-to-date knowledge of EU regulatory requirements and changes in legislation impacting product development and marketing authorisation. Liaise with external partners, consultants, and Health Authorities as needed to support dossier development and submission activities. To be considered for the role of Regulatory Affairs Manager, you will have the following: Proven experience in Regulatory Affairs within the pharmaceutical industry, with a strong focus on EU submissions, ideally minimum of 5 years. Direct experience with EMA and Centralised Procedures is essential - Experience with DCP and MRP pathways is advantageous. Strong working knowledge of CTD Modules 1 5, with demonstrable experience in authoring and reviewing content. Solid understanding of clinical trial data, particularly Phase III studies, and CMC documentation. Ability to independently perform regulatory due diligence for potential product acquisitions. Highly detail-oriented, with strong analytical and communication skills. Educated to Degree level in a scientific discipline This is a permanent role, hybrid working from the companies Slough based offices. Must be able to commute 3 days per week. Unable to sponsor, all applicants must hold valid Right to Work status for the UK.