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.