Regulatory Affairs CMC Manager

Full Job Description

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 .

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.