CK Group are recruiting for a CMC Regulatory Affairs Senior Manager to join a biopharmaceutical company either from home or at their site based in Uxbridge on a on a contract basis for 12 months.
CMC Regulatory Affairs Senior Manager Role:
- Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
- Oversee and 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 submissions (e.g. clinical trial, variations, extensions and marketing applications) for products within Amgen\'s portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
- Leads development of regional regulatory documents (briefing books) and meetings in accordance with global regulatory strategy
- Authoring and coordinating responses to questions across assigned products and countries.
- CMC- specific regulatory knowledge & experience within biotechnology
- Direct experience with EU and EM market applications - MAAs or variation
- BS (MS or higher preferred) life sciences, engineering or related field
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This CMC Regulatory Affairs Senior Manager role will be based at our clients site in Uxbridge, Greater London.
For more information, please contact Lucy or Andy at CK Group. Please quote reference 49043.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: 49043
- Posted: 9th October 2020
- Expires: 6th November 2020