Regulatory Affairs Specialist

4 weeks ago


High Wycombe, United Kingdom LanceSoft, Inc. Full time

**Role Overview**

LanceSoft, Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our EMEA Regulatory Affairs team, you will play a crucial role in ensuring the compliance of our products with EU regulations.

Key Responsibilities:

  1. Support the EMEA Regulatory Affairs team in the management of post-approval activities for specified OTC products.
  2. Develop regulatory strategies, prepare regulatory applications, and support maintenance activities for MRP/DCP products.
  3. Coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
  4. Support the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
  5. Support the team with regional regulatory strategies in line with business plan for post-approval activities.
  6. Support the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  7. Prepare and compile regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions, and other correspondence in accordance with EU regulations and guidelines.
  8. Ensure Marketing Authorisations are maintained and renewed.

Requirements:

  1. Life sciences or chemistry graduate to honours level or equivalent.
  2. Strong understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc.

What We Offer:

At LanceSoft, Inc., we offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a highly motivated and organized individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.



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