Hobson Prior are working with a leading independent biotech organisation who are looking for a UK CW Regulatory Affairs Manager to join them on a contract basis in Uxbridge. This position will play a key role in developing and implementing CMC regulatory strategies for new marketing authorisation applications and throughout whole product lifecycle for the European and extended European region.
- Responsible to ensure 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 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.
- Inputs into the regional regulatory documents (briefing books) and meetings in accordance with global regulatory strategy.
- Authoring and coordinating responses to questions across assigned products and countries.
- Delivers regulatory input on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and pediatric plan).
- Gathering, consolidating and analysing regulatory intelligence for the EU region and support its application to product-specific activities.
- Represent as the first point of contact with local country regulatory staff.
- Project management of submissions and monitoring status of applications.
- Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders.
- Strong team player with a commitment to customer service.
- In-depth experience of pharmaceutical/biotechnology or medical device industry.
- Strong communication skills - oral and written Organizational skills.
- BS (MS or higher preferred) life sciences, engineering or related field.
- 5-10 years related experience within Regulatory Affairs.
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.