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8 Nov
2022
Contract Regulatory Affairs Manager
Job Description
31872 – Regulatory Affairs Manager
£58.19ph
UK home based – must be based in the UK upon application with valid right to work
6 month contract
37.5 hours per week
Description
This role will support one or more products from a regional regulatory perspective.
- 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 client’s 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 our 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
Requirements
- 4+ years of CMC Regulatory Affairs experience concerning biologics products
- Ability to demonstrate working independently
- Strong communication skills
Please note – applicants from outside the UK will not be considered for this role.
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