Regulatory Affairs Manager

4 weeks ago


High Wycombe, Buckinghamshire, United Kingdom BTA Full time
Regulatory Affairs Manager

ClinChoice is seeking an experienced Regulatory Affairs Manager to join our team in High Wycombe, UK. As a key member of our Regulatory Affairs team, you will be responsible for managing post-approval activities for specified OTC products, developing regulatory strategies, and preparing regulatory applications.

Key Responsibilities:

  • Support the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across EEA and coordinate work-sharing procedures for CMC and non-CMC variation.
  • Develop regulatory strategies and prepare regulatory applications for MRP/DCP products.
  • Support the team with regulatory activities for European procedures, including Decentralised, Mutual Recognition, and Work-Sharing procedures.
  • Support the team with regional regulatory strategies in line with business plans for post-approval activities.
  • Prepare and compile regulatory submissions, responses to Regulatory Agency questions, and other correspondence in accordance with EU regulations and guidelines.

Requirements:

  • Life sciences or chemistry graduate to honours level or equivalent.
  • Experience in regulatory affairs, with a strong understanding of EU regulations and guidelines.
  • Excellent communication and project management skills.

About ClinChoice:

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.



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