Regulatory CMC Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the implementation of global regulatory CMC for a variety of marketed products.

• Prepare and file regulatory CMC documentation, including submissions related to clinical trials.

• Offer regulatory support to cross-functional teams, particularly in the area of Biologics.

• Implement the commercial Lifecycle Management strategy and submissions targeting the US, Canada, and Europe.

• Review the CMC sections of regulatory submissions and manage interactions and responses with regulatory bodies.

• Formulate global regulatory CMC strategies and submissions in collaboration with regulatory colleagues.

• Engage in cross-functional team initiatives.

• Act as the primary regulatory CMC liaison for designated products and projects.

⛳️ Requirements

• A Bachelor's degree, ideally in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or a related life-science discipline.

• Generally requires 4 years of experience in the pharmaceutical sector or a related field, or a suitable combination of education and experience.

• In-depth knowledge of FDA, EMA, Health Canada, and ICH regulatory standards.

• Comprehensive understanding of cGMP, FDA, EMA, and ICH guidelines.

• Excellent problem-solving abilities.

• Strong skills in planning and prioritization.

• Capacity to collaborate and communicate in an open, clear, thorough, timely, and consistent manner.

• Ability to engage with all levels of management.

• Strong interpersonal skills for exchanging complex information and guiding others.

🏝️ Benefits

• Overtime compensation in line with federal and state regulations.

• Compensation and medical benefits will be detailed by the third-party agency partner upon offer.

• Additional fringe benefits and employment terms will be outlined by the third-party agency partner upon offer.