Senior Regulatory Affairs Associate CMC

Hays Life Sciences ,
London, Greater London
More Details
Salary: £20.00 - £30.00 per hour

Overview

Senior Regulatory Affairs Associate, CMC, contract job, bio-pharmaceutical Senior Associate CMC Regulatory Affairs Your new company This well known biopharmaceutical company are looking for an experienced Regulatory Affairs Associate to join the business on a contracting basis as a Senior Regulatory Affairs Associate in the CMC team, this is a 12 month contract with scope for extension Your new role As Senior CMC Regulatory Affairs Associate you will be responsible for preparing the Quality sections of INDs/IMPDs, new MAAs, CMC variations and renewals for submission in global markets, ensuring that dossiers meet ICH and local regulatory requirements. You will co-ordinate the preparation of responses to CMC questions from regulatory authorities and work with pharmaceutical development, manufacturing, QA and external partners to deliver CMC Quality components for regulatory submissions in global markets in accordance with corporate objectives or post-licensing commitments. It is a key responsibility of a Senior CMC Regulatory Affairs Associate to maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the business in a timely manner. What you'll need to succeed In order to be considered for this contract job as Senior CMC Regulatory Affairs Associate you must have experience in the preparation and maintenance of CMC components of regulatory submissions and a general understanding of CMC regulatory requirements and quality guidelines, including ICH and regional requirements. What you need to do now For more information on this or any other Regulatory Affairs CMC contract jobs please apply to this advert and ask for Victoria Dunlop This job was originally posted as www.totaljobs.com/job/89929522

People also viewed