Contract Regulatory Affairs Manager

i-Pharm Consulting – Posted by Jeanne – England

Job Description

31872 – Regulatory Affairs Manager

£58.19ph

UK home based / Uxbridge

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

Please note – applicants from outside the UK will not be considered. You must have the right to work in the UK upon application for this role.

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