Regulatory Affairs Specialist

3 weeks ago


High Wycombe, Buckinghamshire, United Kingdom CK Group- Science, Clinical and Technical Full time

Job Title: Regulatory Affairs Manager

Job Type: Contract

Industry: Pharmaceutical

Location: High Wycombe

About the Role:

The successful Regulatory Affairs Manager will be responsible for managing post-approval activities for specified OTC products, supporting the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across the EEA, and coordinating worksharing procedures for CMC and non-CMC variations when appropriate.

Key Responsibilities:

  • Develop regulatory strategies, prepare regulatory applications, and support maintenance activities for MRP/DCP products.
  • Support the team with regulatory activities for European procedures, including Decentralised, Mutual Recognition, and Worksharing procedures, as appropriate.
  • Support the team with regional regulatory strategies in line with the business plan for post-approval activities.
  • Support the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • Prepare and compile regulatory submissions, responses to Regulatory Agency questions, and other correspondence in accordance with EU regulations and guidelines.
  • Maintain and renew Marketing Authorisations.

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 to meet department and company objectives.
  • Technical guidance on a variety of problems of moderate scope and complexity.
  • Project management, understanding of the regulatory environment, interaction with Regulatory Authorities (as appropriate), commercial/strategic awareness, and implementation of regulatory strategy.

About Us:

Our client is the largest and most broadly-based healthcare company, striving to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere.

Working Arrangements:

This role is hybrid working with 2/3 days per week based in High Wycombe.

Essential Requirements:

  • Entitlement to work in the UK.

DBS Check:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.



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