Director or Senior Director of Regulatory Affairs Strategy

Barinthus Biotherapeutics; Harwell; Hybrid; GBP 100,000 - 150,000; Full time

Job summary

A biotherapeutics company in Harwell is seeking a Senior Director or Director of Regulatory Affairs Strategy to lead global regulatory strategy. The role involves managing regulatory documents and aligning strategies with product development. Ideal candidates will have expertise in biologics regulation and a proven track record with global regulatory knowledge. This position offers a salary range of £100,000 to £150,000, along with benefits including flexible working arrangements.

Benefits

Flexible Work-Life Balance

Pension plans

Healthcare

Share options

Qualifications

• Experience in the regulation of biologics and immunomodulating therapies.
• In-depth experience with clinical and non-clinical regulatory aspects.
• Strong experience with biologics registration requirements in Europe.

Responsibilities

• Lead the global regulatory strategy for immunotherapeutic products.
• Manage strategic regulatory documents and interactions with agencies.
• Align regulatory strategies with product development plans.

Skills

Biologics Regulation Expertise

Product Development Insight

Global Regulatory Knowledge

Regulatory Lifecycle Proficiency

Submission Mastery

Job description

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Director or Senior Director of Regulatory Affairs Strategy, Harwell

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Client:

Barinthus Biotherapeutics

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

906a3e2a22fa

Job Views:

6

Posted:

12.08.2025

Expiry Date:

26.09.2025

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Job Description:

Senior Director or Director of Regulatory Affairs Strategy

Hybrid Working - 3 days onsite, 2 days working from home

Salary Range: £100,000 to £150,000

Barinthus Biotherapeuticsis on a quest for aSenior Director or Director of Regulatory Affairs Strategywho is not just looking for a job, but a calling. With us, you’ll embark on a journey of discovery, guiding the immune system to conquer chronic diseases, autoimmunity, and cancer.

What’s in it for you?

• Be a Trailblazer: Be part of a rapidly growing business that’s reshaping the healthcare landscape.
• Flexible Work-Life Balance: Enjoy our flexible working policy, with the option to work from home for up to two days per week.
• Empowering Benefits: From pension plans to healthcare, and share options, we invest in your future.
• Innovative Culture: Work in an environment that valuesLeading By Example, isTeam Focus, Acting With Impact, and upholdsTrust and Respectall toDeliver Excellence.

What you’ll be doing:

• Strategize for Success: Lead the global regulatory strategy for our cutting-edge immunotherapeutic products.
• Drive Regulatory Excellence: Manage strategic regulatory documents and interactions with global agencies.
• Collaborate for Impact: Align regulatory strategies with product development plans, working with diverse teams.

Essential skills and requirements:

• Biologics Regulation Expertise: Experience in the regulation of biologics, including immunomodulating therapies and vaccines, is highly valued.
• Product Development Insight: In-depth experience with clinical and non-clinical regulatory aspects of products in development.
• Global Regulatory Knowledge: Strong experience with biologics registration requirements in Europe and familiarity with international regulations (UK MHRA essential, US FDA preferred).
• Regulatory Lifecycle Proficiency: Solid understanding of Regulatory Life Cycle Management and eCTD format for regulatory filings.
• Submission Mastery: Demonstrated ability in drafting and organizing regulatory submissions, amendments, and supplements.

The Time to Act is Now!Don’t miss this chance to make a real difference.Apply todayand join a team that’s not just part of the industry, but leading it.Barinthus Biotherapeuticsis more than a company—it’s a beacon of hope and innovation.Apply nowand let’s navigate towards a healthier world together.

Barinthus Biotherapeuticsawaits your expertise. Are you ready to guide us into the future?Apply now and let your career set sail with us.

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