Regulatory Affairs CMC Manager
Job details
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.
- 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.
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