Senior Manager Global Regulatory Affairs

JR United Kingdom; Plymouth; On-site; GBP 75,000 - 100,000; Full time

Job summary

A leading recruitment agency in Plymouth is seeking a Senior Manager for Global Regulatory Affairs to provide strategic leadership and ensure compliance with global regulations. The ideal candidate will have a BSc in a related field and extensive experience in regulatory affairs, particularly with ATMPs and Rare Diseases. Responsibilities include managing regulatory interactions and developing company policy. This role offers a chance to influence growth in a dynamic environment.

Qualifications

• In-depth Regulatory Affairs experience across the EU and US.
• Experience with ATMP and/or Rare Disease products.
• Strong leadership and negotiation skills.

Responsibilities

• Act as subject matter expert on global regulatory requirements.
• Provide strategic and operational regulatory leadership.
• Lead regulatory interactions with authorities like FDA and EMA.

Skills

Regulatory Strategy Development

Leadership

Communication

Negotiation

Problem-Solving

Education

BSc or equivalent in life science or legal discipline

Job description

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Senior Manager Global Regulatory Affairs, plymouth

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Client:

Mantell Associates

Location:

plymouth, 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.