Director Or Senior Director Of Regulatory Affairs Strategy

Senior Director or Director of Regulatory Affairs Strategy

Location: Harwell, UK

Hybrid Working

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 or in our Harwell office.
• 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 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 (US FDA, UK MHRA).
• 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.

** To request a full job description please email recruitment@barinthusbio.com **

Notice to recruiters

Barinthus Biotherapeutics' internal Talent Acquisition leads recruitment and employment for Barinthus Biotherapeutics. Unsolicited resumes sent to Barinthus Biotherapeutics from recruiters do not constitute any type of relationship between the recruiter and Barinthus Biotherapeutics and do not obligate Barinthus Biotherapeutics to pay fees should we hire from those resumes. Barinthus Biotherapeutics operate a preferred list of recruitment suppliers, any and all enquiries about joining us as a supplier should be directed to Barinthus Biotherapeutics' TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees. To enquire about partnership please email recruitment@barinthusbio.com