Regulatory Affairs Specialist
4 weeks ago
**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:
- Support the EMEA Regulatory Affairs team in the management of post-approval activities for specified OTC products.
- Develop regulatory strategies, prepare regulatory applications, and support maintenance activities for MRP/DCP products.
- Coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
- Support the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
- Support the team with regional regulatory strategies in line with 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 (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions, and other correspondence in accordance with EU regulations and guidelines.
- Ensure Marketing Authorisations are maintained and renewed.
Requirements:
- Life sciences or chemistry graduate to honours level or equivalent.
- 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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