Senior Manager Global Regulatory Affairs

JR United Kingdom; Southampton; On-site; GBP 70,000 - 95,000; Full time

Job summary

A leading recruitment agency is seeking a Senior Manager for Global Regulatory Affairs based in Southampton. The role involves providing regulatory leadership, managing interactions with authorities, and ensuring compliance across global regulations. Ideal candidates will have significant experience in Regulatory Affairs, particularly with ATMPs and Rare Diseases. This is an exciting opportunity in a growing biomedical research organization.

Qualifications

• In-depth Regulatory Affairs experience across the EU and US.
• Proven experience with ATMP and/or Rare Disease products.
• Familiarity with expedited programs such as breakthrough designation.

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 Affairs Expertise

Leadership Skills

Strategic Planning

Communication

Education

BSc or equivalent in life sciences or legal discipline

Job description

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Senior Manager Global Regulatory Affairs, southampton

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Client:

Mantell Associates

Location:

southampton, 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.