Regulatory Affairs Specialist
1 week ago
CK Group is seeking a highly skilled Regulatory Affairs Manager to join their team. This is a contract role based in High Wycombe, requiring a strong understanding of post-approval activities for OTC products.
Key Responsibilities:
- Support the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across the EEA, coordinating worksharing procedures as needed.
- Develop regulatory strategies, prepare regulatory applications, and maintain activities for MRP/DCP products.
- Collaborate with the team to implement regional regulatory strategies in line with the business plan for post-approval activities.
- Support the team in completing regulatory activities to ensure all 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:
- Lifesciences 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.
- Strong technical guidance skills to determine and develop approaches to solutions with moderate scope and complexity.
- Project management skills, understanding of regulatory environment, interaction with Regulatory Authorities, commercial / strategic awareness, and implementing regulatory strategy.
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