Regulatory Affairs Manager - CMC
PE Global is currently recruiting for a Regulatory Affairs Manager - CMC for our leading multi-national Biotech client based in Cambridge.
The Regulatory Professional will play a key role in developing and executing CMC regulatory strategies for new marketing authorisation applications and throughout whole product lifecycle for the European and extended European region.
• Ensuring 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 client'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.
• Provides 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
Education and experience:
- 5-7 years related experience within Regulatory Affairs in Biotech/Pharma
- BS (MS or higher preferred) life sciences, engineering or related field
- CMC- specific regulatory knowledge & experience within biotechnology
- Direct experience with EU and EM market applications – MAAs or variations
Interested candidates should submit an updated CV.
Please click the link below to apply, call Amparo on +44 0203 86 86 203 or alternatively send an up to date CV
Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.
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