Manager, RA CMC

About the Role

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) works with internal and external partners to deliver products to patients. This role prepares CMC regulatory strategies for first-pass approvals, develops and manages content strategy for regulatory submissions, and builds relationships within Regulatory Affairs, Operations, and Research & Development (R&D). The position represents RA CMC on product development and life-cycle management teams, providing strategic advice to peers in RA, R&D, and Operations.

Responsibilities

• Prepares CMC regulatory product strategies and submissions, including new IND/CTA applications, amendments, renewals, annual reports, supplements, and variations with limited supervision.
• Analyzes and interprets information impacting regulatory decisions; seeks expert advice and technical support as needed.
• Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies.
• Responds to global regulatory information requests under limited supervision.
• Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages.
• Manages products and change control in compliance with regulations, agency guidance, and company policies; analyzes and approves manufacturing change records.
• Represents CMC regulatory affairs on cross-functional teams (e.g., product development, Global Regulatory Product Teams, Operations Product Teams) to negotiate, influence, and maximize first-pass approval chances.
• Analyzes legislation, regulation, and guidance to provide insights to the organization.
• Contributes to white papers and policies illustrating current regulatory thinking; participates in RA CMC initiatives.
• May act as a formal or informal mentor to others.

Qualifications

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

Benefits

• Comprehensive package including paid time off (vacation, holidays, sick leave).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.