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Regulatory Affairs Manager

4 months ago

Uxbridge, United Kingdom Proclinical Staffing Full time

Proclinical is seeking a dedicated Regulatory Affairs Manager. This role involves supporting multiple products from a global and international regulatory perspective. The successful candidate will be responsible for generating country-specific regulatory strategies, interfacing with affiliate offices, and ensuring regional issues impacting global regulatory strategy are considered and addressed.

Responsibilities:

Generate country-specific regulatory strategies and provide feedback to internal teams regarding submission plans.

Interface with affiliate offices for strategies or activities that impact a specific country.

Ensure regional issues impacting global regulatory strategy for proposed filings are considered, with risks identified and appropriate contingency strategies in place.

Review the preparation of M2 and 3 CMC components of filings and assess their suitability for submission in the relevant countries.

Manage strategy and execution for all regulatory CMC submissions in compliance with global filing plans and local regulatory requirements.

Author and coordinate responses to questions across assigned products and countries.

Communicate regional needs for ensuring reliability of the supply chain and successful launch in collaboration with relevant regional stakeholders.

Provide guidance for regulatory assessments of change control requests.

Set project timeframes and priorities based on project objectives and ongoing assignments.

Gather, consolidate and analyse regulatory intelligence for International Markets and support its application to product-specific activities.

Share regulatory information and implications with stakeholders on an ongoing basis and provide advice on regional considerations.

Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the products.

Key Skills and Requirements:

Strong understanding of global and international regulatory perspectives.

Ability to generate and implement regulatory strategies.

Excellent communication and coordination skills.

Ability to manage multiple projects and priorities.

Knowledge of legislation, regulatory policy, and technical Regulatory guidance.


Interested or know someone who might be? Reach out to using the following:



Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. is acting as an Employment Agency in relation to this vacancy.