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Senior Manager Global Regulatory Affairs, northampton
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Client:
Mantell Associates
Location:
northampton, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Views:
1
Posted:
22.08.2025
Expiry Date:
06.10.2025
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Job Description:
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.
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