Regulatory Affairs Manager

UK CW Regulatory Affairs Manager (Inside IR35)

12 month contract

37.5 hours per week

£57.39ph inside IR35

Home based/Uxbridge

You must be based in the UK to be considered for this role

Responsibilities
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.

* 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 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

Requirements

- 5+ years experience in Biologics CMC Regulatory Affairs

- Valid right to work in the United Kingdom