Regulatory Affairs CMC Manager

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:
This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing plans.
Skills & Requirements:
Knowledge of regulations and guidelines governing the development, licensure, and marketing of chemical drugs, biologics, or gene therapies.
Strong project management skills.
Excellent communication and collaboration skills.
Ability to identify issues and develop risk mitigation strategies.
The Regulatory Affairs CMC Manager will:
Represent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
Manage the compilation of all necessary documentation for commercial regulatory CMC submissions and responses to questions, ensuring high quality and compliance with regulations and guidelines.
Collaborate with U.S. and UK teams to prepare change controls and GMP documentation to support global submissions for product registrations and/or renewals.
Participate in cross-functional project teams as a regulatory CMC representative, ensuring consistent communication within the department and with other functional areas.
Proactively identify issues and suggest appropriate strategies to mitigate risks.
Assist 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
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Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.