Regulatory Affairs Consultant

5 hours ago

Bishop's Stortford, Hertfordshire, United Kingdom Scendea Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Scendea. As a key member of our regulatory affairs department, you will play a critical role in providing strategic and technical solutions to complex product development challenges.

This includes:

  • Developing innovative drug development plans, data gap analyses, and international regulatory strategies for complex products within the changing regulatory environment.
  • Contributing to technical authorship and review of development regulatory documents, including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice, and Meeting Briefing Documents.
  • Representing clients in regulatory agency interactions and providing regulatory solutions to agency objections.
  • Collaborating across jurisdictions and disciplines to deliver expert consulting services.
About You

We are looking for a high-calibre individual with a life science-focused BSc (or equivalent) and a higher degree in a biomedical field or equivalent (e.g., a life science-focused MSc or PhD). Your experience should include 8-10 years of drug development experience, 8-10 years of experience with FDA, MHRA, and/or EMA, including negotiation, and direct experience in providing strategic regulatory planning from early-stage development up to marketing authorisation.

A UK resident with the right to work in the UK without the need for sponsorship is essential.

What We Offer

In return for your expertise, we offer a competitive salary (£80,000 - £100,000), generous bonus program, 26 days' holiday plus public holidays, employer pension contribution, private healthcare insurance, access to an Employee Assistance Programme, and an Employee Ownership Trust Scheme.

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