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