An excellent opportunity has arisen for a Regulatory Affairs Manager to join my clients CMC team on an initial 6 month contract basis, with potential to extend.
You will ideally have upwards of 5 years of experience, a strong CMC background (authoring and review of Module 2.3 and 3), strong global strategy experience as well as experience within biologics.
This role will support one or more products from a regional regulatory perspective.
Resposibilities include:
- 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 the company 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 clients 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 analyzing 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.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
For further details, please contact Tim Barratt on +44 (0)1727 817 626 or email tbarratt@achieva.co.uk
- Agency: Achieva Group Limited
- Reference: BH-34645
Website: Achieva Group Limited
- Posted: 18th May 2023
- Expires: 15th June 2023
