Senior RA CMC Manager
- Posted 17 October 2022
- LocationUxbridge
- Job type Permanent
- Reference70389
- Contact NameDavid Skinner
Job description
SENIOR RA CMC MANAGER
Key responsibilities include:
· Responsibility for the generation and execution of international country specific regulatory strategies
· Accountable for management of regional CMC filings from marketing authorisation to post-approval supplements, renewals and responses to questions across assigned products and countries for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
· Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered
· Review and preparation of M2 and 3 components for International Clinical Trial Applications, Marketing Applications and post-market supplements/variations
· Authoring and coordinating responses to questions across assigned products and countries.
· Gathering, consolidating and analysing regulatory intelligence for International Markets and supports its application to product-specific activities
· Project management of submissions and monitoring status of applications
· Provides guidance for and performs regulatory assessments of change control requests
· Provide regional/country, product & regulatory expertise and clarification on International CMC RA requirements
Qualifications and skills:
· Master’s or Bachelor’s degree or equivalent
· Regulatory Affairs experience
· Creation and execution of regional regulatory strategies
· CMC specific regulatory knowledge and experience or in the manufacture/testing of pharmaceutical products
· Direct experience with International market applications – MAAs or variations
· Good understanding of the direct experience of ex US filings
· Excellent communication skills with ability to communicate across all levels
· Project management skills with ability to work well with others in demanding situations
· Ability to work in a fast-paced environment
· Current knowledge and application of CMC hot topics and knowledge of International legislation and guidance for biotechnology products
· Strong MS Office skills