Strategic Regulatory Planning Specialist

15 hours ago


Bishop's Stortford, Hertfordshire, United Kingdom Scendea Full time
Job Summary

As a Regulatory Affairs Specialist at Scendea, you will be responsible for providing regulatory guidance and innovative strategies across a wide range of medicinal product development activities.

You will:

  • Develop and implement regulatory strategies for complex products.
  • Contribute to technical authorship and review of development regulatory documents.
  • Represent clients in regulatory agency interactions.
  • Collaborate with cross-functional teams to deliver expert consulting services.
About the Team

Our team is made up of industry-leading experts in a fast-paced, supportive environment. With over 50 staff based in the UK, Netherlands, Australia, and the US, we are undergoing significant growth, with new office locations and service lines to facilitate the delivery of expert and strategic global regulatory consulting services.

What We Are Looking For

We seek a dynamic and competent scientist with 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.



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