Regulatory Affairs Specialist
1 month ago
Regulatory Affairs Manager Role:
As a Regulatory Affairs Manager at CK Group, you will be responsible for managing post-approval activities for specified OTC products. This includes supporting the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinating worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
You will develop regulatory strategies, prepare regulatory applications, and support maintenance activities for MRP/DCP products. Additionally, you will support the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
Your key responsibilities will include:
- Supporting the team with regional regulatory strategies in line with business plan for post-approval activities.
- Supporting the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
- Preparing and compiling regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions, and other correspondence in accordance with EU regulations and guidelines.
- Ensuring Marketing Authorisations are maintained and renewed.
Your Background:
To be successful in this role, you will have a life sciences or chemistry graduate to honours level or equivalent. You will work with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
You will have the ability to work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity. Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc.
Company:
Our client is the largest and most broadly-based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
Location:
This role is hybrid working with 2/3 days per week based in High Wycombe.
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