Regulatory Affairs Manager

1 month ago

High Wycombe, Buckinghamshire, United Kingdom ClinChoice Full time
Regulatory Affairs Manager Opportunity

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, supporting the EMEA Regulatory Affairs team, and developing regulatory strategies.

Key Responsibilities:

  • Management of post-approval activities for specified OTC products
  • Supports the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate work-sharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
  • Development of regulatory strategies, preparation of regulatory applications, and support maintenance activities for MRP/DCP products
  • Supports the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
  • Supports the team with regional regulatory strategies in line with the business plan for post-approval activities.
  • Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • Prepares and compiles regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions, and other correspondence in accordance with EU regulations and guidelines.
  • Ensures compliance within the department by ensuring EAME databases (RegPoint, HAQ) are fully maintained.
  • Supports the EMEA RA team with consolidated Calls for Information (CFI) and coordinate submission of PSUSA.
  • Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the VP Regulatory Affairs in European Regulatory.
  • Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
  • Maintain awareness/knowledge of current regulatory legislation.
  • Ensures regulatory best practice at all times.
  • Monitor changes in the regulatory environment and highlight any potential impact on the products.

Requirements:

  • Life sciences or chemistry graduate to honours level or equivalent.
  • Works with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
  • Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
  • Project management, understanding of the regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial/strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc.

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 Company Ethos:

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 they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.

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