Manager, RA CMC

Purpose:

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals with limited management supervision. Develops content strategy for regulatory submissions (INDs/CTAs and amendments, supplements/variations), builds relationships across Regulatory Affairs, Operations, and R&D, and represents RA CMC on product development and life-cycle management teams.

• Prepares CMC regulatory product strategies and regulatory submissions (new IND/CTA applications, amendments, renewals, annual reports, supplements, variations).
• Analyzes and interprets information impacting regulatory decisions; seeks technical support as needed.
• Reviews and revises submission documentation for effective presentation of data/strategy to agencies.
• Responds to global regulatory information requests.
• Develops strategies for CMC-related agency interactions and manages agency meeting requests/information packages.
• Manages products and change control; analyzes and approves manufacturing change records.
• Represents CMC regulatory affairs on cross-functional teams; negotiates/influences to maximize first pass approval.
• Analyzes legislation, regulation, and guidance; provides analysis to the organization.
• Contributes to creation of white papers and policies; participates in RA CMC initiatives.
• May mentor others.

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject.
• Relevant advanced degree preferred; certification a plus.
• 6 years biopharmaceutical or related industry experience.
• Preferred: 6 years RA, R&D or Operations experience (including 3 years in regulatory affairs responsibilities) and experience in complex, matrix environments.
• Strong oral and written communication skills.