CMC Regulatory Affairs Manager

This position is responsible for preparation of CMC submissions for Biologics products. This position will also assist the Regulatory CMC team with special projects as assigned.

• Responsible for implementing regulatory strategies, including filing of all appropriate regulatory submissions for assigned programs.

• Responsible for coordinating all aspects of regulatory CMC submissions relevant to assigned projects or programs
• Identify and assess regulatory risks associated with product development for assigned programs. Assist in defining strategies to mitigate risks
• Guide the organization and preparation of clear and effective submissions.
• Ensures completion of high-quality submissions, adhering to regulatory guidelines, regional specifications, and company standards
• Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on specific projects
• Assess compliance of CMC document with the current Guidelines and Regulations
• Assess regulatory impact of proposed CMC changes to licenses or clinical trial applications