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Regulatory Affairs Manager

  1. Remote
Remote work
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
18-05-2023
31383

This vacancy has now expired

Regulatory Affairs Manager- Life Science- Contract- Remote

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Regulatory Affairs Manager. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.

Regulatory Affairs Manager Responsibilities:
  • Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more products.
  • Interfaces with affiliate offices for specific strategies or activities that impact a specific country.
  • Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
  • Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
  • Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications) for products within the client's portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.Authoring and coordinating responses to questions across assigned products and countries.
  • Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
  • Provides guidance for regulatory assessments of change control requests
  • Sets project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints
  • Gathering, consolidating, and analysing regulatory intelligence for International Markets and supports its application to product-specific activities
  • Share regulatory information and implications with the 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 client's products.
  • Performs regulatory research to obtain relevant histories, precedence, and other information relevant to regional product advancement.
Are you a good fit for a Regulatory Affairs Manager? Get in touch with us today.

The candidate must have the rights to work in the location stated in the job advert.

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