Regulatory Affairs Manager

2 weeks ago


High Wycombe, Buckinghamshire, United Kingdom ClinChoice Inc. 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 EMEA Regulatory Affairs team, you will be responsible for supporting post-approval activities for MRP/DCP products across the EEA and coordinating work-sharing procedures for CMC and non-CMC variations.

Key responsibilities include:

  • Developing regulatory strategies and preparing regulatory applications for MRP/DCP products
  • Supporting the team with regulatory activities for European procedures, including Decentralised, Mutual Recognition, and Work-Sharing procedures
  • Ensuring compliance with EU regulations and guidelines
  • Providing regulatory advice and performing due diligence for product acquisitions and distributor agreements

Requirements:

  • Life sciences or chemistry graduate to honours level or equivalent
  • Experience in regulatory affairs, preferably in the pharmaceutical industry
  • Strong knowledge of EU regulations and guidelines
  • Excellent communication and project management skills

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and a supportive culture. We offer a competitive salary and benefits package, as well as opportunities for career growth and development.



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