Type of Role

Contract position, Inside IR35

Location

Hybrid, 3 days on site in Paddington, London.

Department

Regulatory – Chemistry Manufacturing Controls

General Summary

The Manager, Regulatory Chemistry Manufacturing Controls will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products.

This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics.

This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.

Key Duties and Responsibilities

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.