Regulatory Affairs Manager

2 weeks ago

High Wycombe, Buckinghamshire, United Kingdom ClinChoice Inc. Full time
Regulatory Affairs Manager/Officer

ClinChoice is seeking an experienced Regulatory Affairs Manager/Officer 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:
  • 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
  • Prepare and compile regulatory submissions, responses to Regulatory Agency questions, and other correspondence in accordance with EU regulations and guidelines
  • Ensure compliance within the department by maintaining EAME databases (RegPoint, HAQ)
  • Support the EMEA RA team with consolidated Calls for Information (CFI) and coordinate submission of PSUSA
  • Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements
  • Maintain awareness/knowledge of current regulatory legislation and ensure regulatory best practice at all times
Requirements:
  • Life sciences or chemistry graduate to honours level or equivalent
  • Experience working with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects
  • Project management, understanding of regulatory environment, interaction with Regulatory Authorities, commercial/strategic awareness, and ability to implement regulatory strategy
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.

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and we are committed to developing and maintaining highly-qualified personnel through continuous training and close management.

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