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

About the role

As Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) – Biologics Product Lead, you will collaborate with internal and external partners to deliver products to patients. You will prepare CMC regulatory strategies aimed at achieving first-pass approvals with limited management oversight, develop and manage content strategies for regulatory submissions, and build relationships across Regulatory Affairs, Operations, and Research & Development (R&D). You will represent RA CMC on product development and lifecycle management teams, providing strategic advice and negotiating with peers to maximize the chances of successful regulatory outcomes.

Responsibilities

• Prepare CMC regulatory product strategies with limited supervision.
• Prepare regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements, and variations under limited supervision.
• Analyze and interpret information that impacts regulatory decisions; seek expert advice and technical support as required for strategies and submissions.
• Review and revise regulatory submission documentation to effectively present data and strategy to regulatory agencies under limited supervision.
• Respond to global regulatory information requests under limited supervision.
• Develop strategies for CMC-related agency interactions and manage preparation of agency meeting requests and information packages under limited supervision.
• Manage products and change control with an understanding of regulations, agency guidance, and company policies and procedures with limited supervision.
• Analyze and approve manufacturing change records with limited supervision.
• Represent CMC Regulatory Affairs on teams such as product development, Global Regulatory Product Teams, and Operations Product Teams for assigned projects; negotiate and influence team members with management support to maximize first-pass approval of regulatory submissions.
• Stay abreast of regulatory procedures and changes in the external regulatory environment.
• Analyze legislation, regulation, and guidance and provide analysis to the organization under limited supervision.
• Contribute to creation of white papers and policies to illustrate current regulatory thinking under supervision of manager.
• Participate in initiatives internal to RA CMC.
• Act as a formal or informal mentor to others.

Qualifications

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

Work Schedule

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

Work Activities

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.