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Head of Regulatory Affairs Strategy
3 months ago
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 Senior Director or Director of Regulatory Affairs Strategy who is ready to make a significant impact in the field of immunotherapy. This role is not merely a position; it is an opportunity to lead the charge in addressing chronic diseases, autoimmunity, and cancer.
What we offer:
- Innovative Leadership: Join a dynamic organization that is transforming the healthcare sector.
- Work-Life Flexibility: Benefit from our adaptable working arrangements, allowing for remote work up to two days a week.
- Comprehensive Benefits: We provide a range of benefits including pension plans, healthcare options, and employee share schemes to support your future.
- Culture of Innovation: Engage in a workplace that emphasizes Leading By Example, Team Collaboration, Impactful Actions, and a commitment to Trust and Respect to Deliver Excellence.
Your Responsibilities:
- Strategic Leadership: Oversee the global regulatory strategy for our innovative immunotherapeutic products.
- Regulatory Management: Direct the preparation of strategic regulatory documents and liaise with global regulatory bodies.
- Collaborative Strategy: Ensure alignment of regulatory strategies with product development initiatives, collaborating with cross-functional 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 Expertise: Comprehensive understanding of Regulatory Life Cycle Management and eCTD format for submissions.
- Submission Proficiency: Demonstrated capability in drafting and organizing regulatory submissions, amendments, and supplements.
Seize the Opportunity: This is your chance to contribute to a pioneering organization that is at the forefront of innovation in healthcare. Barinthus Biotherapeutics is not just a company; it is a leader in the industry, dedicated to advancing health solutions. We invite you to explore this opportunity and consider how your expertise can shape the future of healthcare.
