Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC)

About the Role

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

Responsibilities

• Prepares CMC regulatory product strategies with limited supervision.
• Develops and manages regulatory submissions, including INDs/CTAs, amendments, renewals, annual reports, supplements, and variations.
• Analyzes and interprets information impacting regulatory decisions; seeks expert advice as needed.
• Reviews and revises regulatory submission documentation to present data and strategy effectively to agencies.
• Responds to global regulatory information requests under limited supervision.
• Develops strategies for CMC-related agency interactions and prepares meeting requests and information packages.
• Manages products and change control in alignment with regulations, agency guidance, and company policies.
• Analyzes and approves manufacturing change records with limited supervision.
• Represents CMC regulatory affairs on product development, Global Regulatory Product Teams, and Operations Product Teams; negotiates and influences team members to maximize first-pass approval chances.
• Stays abreast of regulatory procedures and external changes; analyzes legislation, regulation, and guidance to provide organizational insights.
• Contributes to white papers and policies illustrating current regulatory thinking under managerial supervision.
• Participates in internal RA CMC initiatives.
• May act as a formal or informal mentor to others.

This position follows a hybrid work schedule (3 days in office) from AbbVie’s Lake County, IL; Irvine, CA; or Waltham, MA headquarters.

Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or a related subject.
• Relevant advanced degree preferred; certification is a plus.
• 6+ years of biopharmaceutical or related industry experience.
• Preferred: 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.

Significant work activities include continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day).

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.