Regulatory Affairs Manager
Slough – Hybrid. Full time, Permanent
The Regulatory Affairs Manager is responsible for delivering and managing regulatory activities across the UK and EU regions. This includes the preparation, submission, and lifecycle maintenance of dossiers for generic products, assessment of CMC documentation for new Marketing Authorisation Applications (MAAs), and supporting the development of regulatory processes within the European Regulatory Affairs function.
Key Responsibilities:
* Lead preparation and submission of MAAs via National, DCP, MRP and Centralised procedures.
* Manage variations, renewals, PSURs, and lifecycle activities for generic products.
* Review and manage CMC/Module 3 and Module 2 (QOS) documentation.
* Maintain product information (SmPC / PIL) and support artwork and compliance activities.
* Work closely with UK/EU affiliates and cross‑functional teams to support launches, portfolio decisions, and regulatory operations.
* Due diligence activities
* Maintain regulatory archives and ensure data accuracy across tracking systems.
Required Experience & Qualifications:
* Degree in Life Sciences or related field.
* 5+ years’ experience in UK/EU Regulatory Affairs, including MA submissions and maintenance.
* Strong, clear evidenced experience with European regulatory frameworks and submission pathways (DCP and CMC are essential)
* Hands-on experience with post-approval activities, variation strategies, line extensions and due diligence activities is essential.
* Familiarity with regulatory tools and platforms (eCTD, CESP, MHRA portal, Eudralink).
* Ability to critically evaluate scientific data and identify regulatory risks and mitigation strategies.
* Excellent communication, project management, and cross-functional collaboration skills.
* Experience managing regulatory timelines and approvals in a fast-paced environment.