Overview

Reference Number: JO-1912-443306
Senior Regulatory Affairs Associate – CMC
Rate: Negotiable
Job Type: Permanent
Location: Cambridge

Senior Regulatory Affairs Associate
Cambridge
International Pharma
Offering up to 55,000 DOE

An exciting research-based bio-pharmaceutical company or strives to discover, develop and commercialise innovative medicines is recruiting for a Global CMC Senior Regulatory Affairs Associate to join their ever-expanding team based in Cambridge. Working as part of the Global Regulatory CMC team you will be working with the team delivering the CMC components for clinical trial applications, new licence applications and post approval submissions for international Rest of World territories.

Job Responsibilities include;

Prepare the quality sections of INDs/ IMPDs, new MAAs, CMC variations and renewals for submission in RoW territories
Coordinate the preparation of responses to CMC questions from regulatory authorities
Liaise with local affiliates to define/ clarify CM submission requirements
Provide advice to pharmaceutical development and manufacturing colleagues on RoW regulatory requirements for new submissions and for post approval change management
Maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner

Candidate Requirements include;

Bachelors degree or above within Lie Sciences or the equivalent
Experience in the preparation and maintenance of CMC components of regulatory submissions
Regulatory Affairs experience in one or more ROW regions is highly desirable
General understanding of CMC regulatory requirements and quality guideline
Excellent written and verbal communication

If this position is of interest to yourself please call Sophie at Regulatory Professionals on 0118 952 2797 or forward your up to date CV to sophie@regulatoryprofessionals.com. Please note you must be eligible to live and work in the UK to progress.

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