Head of Regulatory Affairs Strategy

1 month ago


Harwell, Oxfordshire, United Kingdom Barinthus Biotherapeutics Full time

Senior Director or Director of Regulatory Affairs Strategy

Location: Harwell, UK

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

Salary Range: £100,000 to £150,000

Barinthus Biotherapeutics is seeking a dedicated Senior Director or Director of Regulatory Affairs Strategy who is passionate about making a significant impact in the field of immunotherapy. This role offers an opportunity to lead the charge in developing innovative solutions for chronic diseases, autoimmunity, and cancer.

What we offer:

  • Innovative Leadership: Be part of a pioneering organization that is transforming the healthcare sector.
  • Work-Life Flexibility: Benefit from our adaptable working policy, allowing for remote work up to two days a week.
  • Comprehensive Benefits: We provide a range of benefits including pension schemes, healthcare, and stock options to support your future.
  • Culture of Innovation: Thrive in an environment that prioritizes Leading By Example, Team Collaboration, Impactful Actions, and Trust and Respect to Achieve Excellence.

Your Responsibilities:

  • Strategic Leadership: Oversee the global regulatory strategy for our advanced immunotherapeutic products.
  • Regulatory Excellence: Manage critical regulatory documents and liaise with global regulatory bodies.
  • Collaborative Approach: Ensure alignment of regulatory strategies with product development initiatives, engaging with diverse teams.

Key Qualifications:

  • Expertise in Biologics Regulation: Proven experience in the regulation of biologics, particularly immunomodulating therapies and vaccines.
  • Insight into Product Development: Extensive knowledge of clinical and non-clinical regulatory processes for products in development.
  • Global Regulatory Acumen: Strong familiarity with biologics registration requirements in Europe and knowledge of international regulations (UK MHRA essential, US FDA preferred).
  • Regulatory Lifecycle Management: Comprehensive understanding of Regulatory Life Cycle Management and eCTD format for submissions.
  • Submission Expertise: Demonstrated proficiency in drafting and organizing regulatory submissions, amendments, and supplements.

Join us in making a difference. At Barinthus Biotherapeutics, we are more than just a company; we are a leader in innovation and hope. Your expertise could help us navigate towards a healthier future.



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