CK Group are recruiting for a Regulatory Affairs Manager to join a global Biotechnology company that develop innovative therapies for serious diseases. The role is initially for 6 months and based from their offices in Uxbridge. There will be some requirement to be onsite but the majority of the time the role can be carried out remotely.
The role is determined as Inside IR35 so working options of PAYE or Umbrella are available.
This is a remote role with attendance on site in Uxbridge, as and when required.
Regulatory Affairs Manager:
The main purpose of the role will be to support one or more products from a regional regulatory perspective. You will be 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. You will interface 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 Amgen'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 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 relating to Amgen products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Extensive experience in regulatory CMC (module 2 & Module 3)
- Regulatory CMC submissions
- Have generated country specific strategies
- Knowledge of drug development
- Cultural awareness and sensitivity to achieve results across both regional country and international borders.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56026 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 56026
Website: CK Group
- Posted: 4th September 2023
- Expires: 2nd October 2023