Regulatory Affairs Specialist

1 month ago


High Wycombe, Buckinghamshire, United Kingdom newscientist - Jobboard Full time

CK Group is seeking a highly skilled Regulatory Affairs Manager to join a leading pharmaceutical company in High Wycombe. This contract role will involve managing post-approval activities for specified OTC products.

Key Responsibilities:
  • Support the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across the EEA and coordinate worksharing procedures for CMC and non-CMC variations.
  • Develop regulatory strategies, prepare regulatory applications, and support maintenance activities for MRP/DCP products.
  • Collaborate with the team to develop regional regulatory strategies in line with business objectives 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.
  • Ability to work with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects.
  • Project management skills, understanding of the regulatory environment, and interaction with Regulatory Authorities.
About the Company:

Our client is a leading healthcare company that strives to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere.

This role is hybrid working with 2/3 days per week based in High Wycombe. Please note that this role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.



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