International Regulatory Strategy Lead job in London

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Our client, a global biotechnology company that employs over 20,000 people across the world, is looking to hire a International Regulatory Strategy Lead. The company specialise in creating breakthrough therapies for rare diseases, and works to produce an innovative pipeline across their key therapy areas. Under the direction of the Head, International Regulatory Strategy, the International Regulatory Strategy Product Lead is responsible for defining the regulatory strategy for assigned products covering International markets (APAC, LATAM, EAMEA and Japan) and providing regional regulatory expertise in collaboration with the International LOC('s),

The individual is responsible and accountable for executing the regional regulatory strategy pertaining to the development, registration and regulatory compliance of company products in the International markets as dictated by company business objectives. This will include interacting with the International LOC team and distributors (where needed) to ensure timely submission and approval for company products in these markets.

Job Responsibilities:

Responsible and accountable for defining the International regulatory strategy for assigned products (maintaining and extending company product registrations in International markets).
Collaborates closely with all other key GRA stakeholders (including but not limited to Global Regulatory Lead, labelling, CMC, regulatory operations, EU regulatory team and regulatory staff in the International LOCs) to ensure that all aspects of the regional strategy is coordinated and considered.
Designs international regulatory strategy for products that they are accountable for in close collaboration with the GRL to obtain, maintain and extend company products registration in the international markets
Ensure international strategy is appropriately represented within the GRT and at other appropriate forums (LPT, Global Development Team etc) through the GRL
Provides regional regulatory expertise to the GRL and within GRT by collaborating with the International LOC
Works in close collaboration with the GRL and International LOC's in providing support to meetings with Health Authorities (where needed).

To Apply:

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In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.