Temp - Senior Manager, Regulatory Affairs

4 weeks ago

London, United Kingdom in Newbury Full time

Job Description Our client, a global pharmaceutical company based in excellent location in North West London, is seeking a talented individual to join their Global Labelling Strategy and Compliance team. As a Labelling Process Management, Senior Associate, you'll have the opportunity to work on projects that shape the global labelling strategy for key pharmaceutical products. With the flexibility to be in the office only twice per week, you can enjoy a healthy work-life balance while making a meaningful impact in the industry.
Collaborate with the Global Regulatory Team to develop and execute regional regulatory strategies
- Manage effective agency interactions and ensure timely regulatory compliance
- Provide expert advice on regional considerations in strategy development and implementation
Profound knowledge of regulatory principles, policies, and procedures
- Ability to navigate regulatory procedures for marketing applications, clinical trials, and post-approval changes
- Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals
- Region Specific Activities EU: Review and approve promotional and non-promotional materials for use in the region EM: Manage the product lifecycle for individual countries per national agency requirements EM: Work through the regional leads to manage distributor markets
- May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. Exposure to a wide range of regional and international regulatory activities
- Chance to lead and mentor regional regulatory leads and support staff
- Advance your career with a global pharmaceutical company renowned for its commitment to quality and innovation
- 12-month contract with the possibility of extension, providing stability and long-term career prospects
This is a 1+ year contract and the client is looking for someone to start as soon as possible so please share your CV if interested, forward to Oksana at -recruitment.Please bear in mind the role is remote but occasional visits to London office are required.

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