Director or Senior Director of Regulatory Affairs Strategy

Barinthus Biotherapeutics

Director or Senior Director of Regulatory Affairs Strategy


Barinthus Biotherapeutics, Chilton, Oxfordshire

  • Full time
  • Permanent
  • Remote working

Posted 1 week ago, 15 May | Get your application in now before you miss out!

Closing date: Closing date not specified

job Ref: 9ae2264805654a3894518438b8ab70bc

Full Job Description

  • 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.

    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 (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.

    Barinthus Biotherapeutics plc is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutics that guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer.

  • The company stands apart through its broad pipeline, built around four proprietary platform technologies; ChAdOx, MVA, SNAP-TI and SNAP-CI. These platforms are enabling the company to develop antigen-specific immunotherapeutics that aim to optimize the disease-fighting capabilities of T cells and guide them towards a healthy balance.

    Leading the way with a passion for science embodies everything we do at Barinthus Biotherapeutics - even our new name. Barinthus was the name of the mythological navigator who guided the legendary King Arthur of Britain by ship to the island of Avalon to be healed after he was wounded.

    Like Barinthus, our company aims to be a strong and resilient guide, navigating those that rely on us toward better health. In this most important journey, our vessel is the power of science and our expertise to harness it in directing the immune system to help people overcome chronic infectious diseases, autoimmunity, and cancer.

    While our eyes are keenly focused on moving science forward, we also draw inspiration from the past. Aligning the name of our company with an Arthurian legend is a nod to our rich UK-based history as a dedicated steward of science and unwavering champion of patients. If the past is prologue for the future, then we proudly embrace the values and technological approach that continue to be the hallmark and fabric of our company - now more than ever as we blaze on as Barinthus Biotherapeutics

  • 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.