Senior Manager Global Regulatory Affairs

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 intelligence
• Provide strategic and operational regulatory leadership across project teams, including resource allocation, risk identification, and mitigation planning
• Lead 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 function
• Drive 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-approval
• Proven experience with ATMP and/or Rare Disease products, with understanding of HTA requirements, accelerated pathways, and conditional approvals within FDA and EMA frameworks
• Demonstrated success in regulatory strategy development, multi-project leadership, and managing high-level regulatory authority interactions
• Strong leadership, communication, negotiation, and organisational skills, with a track record of creative problem-solving and effective issue management in regulatory contexts
• Familiarity 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.