Regulatory Affairs Director

3 weeks ago


High Wycombe, Buckinghamshire, United Kingdom LanceSoft, Inc. Full time
Job Title: Regulatory Affairs Manager

Location: Hybrid

We are seeking a highly skilled Regulatory Affairs Manager to join our team at LanceSoft, Inc. in High Wycombe, HP12 4PT.

Job Summary

The successful candidate will be responsible for 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.

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 Worksharing
  • Develop regional regulatory strategies in line with business plans for post-approval activities
  • 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 and coordinating submission of PSUSA
  • Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements
  • Maintain awareness of current regulatory legislation and ensure regulatory best practice at all times
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 and commercial/strategic awareness
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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