Regulatory Affairs CMC Manager

2 weeks ago

Leeds, Leeds, United Kingdom Proclinical Staffing Full time
Regulatory Affairs CMC Manager - Remote - Contract

Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.

Primary Responsibilities:

nThis role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing plans.


Skills & Requirements:

nKnowledge of regulations and guidelines governing the development, licensure, and marketing of chemical drugs, biologics, or gene therapies.nStrong project management skills.nExcellent communication and collaboration skills.nAbility to identify issues and develop risk mitigation strategies.


The Regulatory Affairs CMC Manager will:nRepresent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.nManage the compilation of all necessary documentation for commercial regulatory CMC submissions and responses to questions, ensuring high quality and compliance with regulations and guidelines.nCollaborate with U.S.

and UK teams to prepare change controls and GMP documentation to support global submissions for product registrations and/or renewals.nParticipate in cross-functional project teams as a regulatory CMC representative, ensuring consistent communication within the department and with other functional areas.nProactively identify issues and suggest appropriate strategies to mitigate risks.nAssist in the preparation for interactions with global regulatory authorities.

If you are having difficulty in applying or if you have any questions, please contact

Caitlin Siljeur

at

.nProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.nProclinical Staffing is an equal opportunity employer.

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