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Regs Manager,

1 month 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.

Responsibilities:

- 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

Requirements:

- Profound knowledge of regulatory principles, policies, and procedures
- Familiarity with relevant legislation and regulations governing medicinal products
- 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. IMT, IBT, NAMT)
- experience in Biologics prducts

Benefits:

- Opportunity to work for a global company with a strong reputation in the industry
- 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
- Work in a prime location in north west London, with easy access to transportation and amenities
- 12-month contract with the possibility of extension, providing stability and long-term career prospects

Interested? Don't miss out on this exciting opportunity Apply today and take your career to new heights. Send me a copy of your CV in Word format or share as this is a great opportunity for the right person 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.com or via linked in. Please bear in mind the role is remote but occasional visits to London office are required.

The job market changes very quickly so do not forget to connect with me on Linked in, check other roles that I am hiring for at the moment and follow for any future relevant roles.

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