Director of Regulatory Affairs Strategy

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 on a quest for a Senior Director or Director of Regulatory Affairs Strategy who 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 values Leading By Example, is Team Focus, Acting With Impact, and upholds Trust and Respect all to Deliver 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 and requirements:
* Biologiskills cs 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 today and join a team that’s not just part of the industry, but leading it. Barinthus Biotherapeutics is more than a company—it’s a beacon of hope and innovation. Apply now and let’s navigate towards a healthier world together.
Barinthus Biotherapeutics awaits your expertise. Are you ready to guide us into the future? Apply now and let your career set sail with us