Job Title

Mantell Associates is currently partnered with an exciting Biomedical Research organisation, who are looking to bring in a Global Regulatory Affairs Senior Manager to take the company to new heights as they continue to grow. Senior Manager Global Regulatory Affairs - Responsibilities:Act as a subject matter expert on global regulatory requirements, including for ATMPs, ensuring company-wide compliance and integrating relevant regulatory intelligenceProvide strategic and operational regulatory leadership across project teams, including resource allocation, risk identification, and mitigation planningLead regulatory interactions with authorities such as the FDA, EMA, and national agencies, while overseeing the preparation and submission of high-quality regulatory documents (e.g., IMPD/CTA/IND, MAA/BLA, orphan drug and breakthrough designation applications)Manage external regulatory service providers to align with business objectives and support the development and maintenance of an effective regulatory affairs functionDrive internal training, ensure regulatory awareness, and contribute to company policies and governance as the organisation evolves Senior Manager Global Regulatory Affairs - Requirements:BSc or equivalent in a life science or legal discipline, with in-depth Regulatory Affairs experience across the EU and US from early development through to post-approvalProven experience with ATMP and/or Rare Disease products, with understanding of HTA requirements, accelerated pathways, and conditional approvals within FDA and EMA frameworksDemonstrated success in regulatory strategy development, multi-project leadership, and managing high-level regulatory authority interactionsStrong leadership, communication, negotiation, and organisational skills, with a track record of creative problem-solving and effective issue management in regulatory contextsFamiliarity with expedited programs such as breakthrough designation and a collaborative approach to cross-functional engagement Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.