Regulatory Affairs Specialist
3 weeks ago
Job Title: Regulatory Affairs Manager
Job Type: Contract
Industry: Pharmaceutical
Location: High Wycombe
About the Role:
The successful Regulatory Affairs Manager will be responsible for managing post-approval activities for specified OTC products, 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 when appropriate.
Key Responsibilities:
- Develop regulatory strategies, prepare regulatory applications, and support maintenance activities for MRP/DCP products.
- Support the team with regulatory activities for European procedures, including Decentralised, Mutual Recognition, and Worksharing procedures, as appropriate.
- Support the team with regional regulatory strategies in line with the 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, responses to Regulatory Agency questions, and other correspondence in accordance with EU regulations and guidelines.
- Maintain and renew Marketing Authorisations.
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 to meet department and company objectives.
- Technical guidance on a variety of problems of moderate scope and complexity.
- Project management, understanding of the regulatory environment, interaction with Regulatory Authorities (as appropriate), commercial/strategic awareness, and implementation of regulatory strategy.
About Us:
Our client is the largest and most broadly-based healthcare company, striving to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere.
Working Arrangements:
This role is hybrid working with 2/3 days per week based in High Wycombe.
Essential Requirements:
- Entitlement to work in the UK.
DBS Check:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
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