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

Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead

Responsibilities:
- Prepare CMC regulatory product strategies and regulatory submissions (new IND/CTA applications and amendments, renewals, annual reports, supplements, variations) under limited supervision.
- Analyze and interpret information impacting regulatory decisions; seek technical support as needed.
- Review and revise submission documentation to present data and strategy to regulatory agencies.
- Respond to global regulatory information requests.
- Develop strategies for CMC-related agency interactions; manage preparation of meeting requests and information packages.
- Manage products and change control; analyze and approve manufacturing change records.
- Represent CMC regulatory affairs on product development, Global Regulatory Product Teams, and Operations Product Teams; negotiate/influence to maximize first-pass approval.
- Analyze legislation/regulation/guidance and provide analysis to the organization.
- Contribute to white papers and policies; participate in internal RA CMC initiatives.
- May mentor others.
- Hybrid work schedule: 3 days in office from AbbVie headquarters (Lake County, IL; Irvine, CA; or Waltham, MA).

Qualifications:
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related.
- Preferred: relevant advanced degree; certification a plus.
- Required: 6 years biopharmaceutical or related industry experience.
- Preferred: 6 years biopharmaceutical RA, R&D or Operations, including 3 years regulatory affairs.
- Experience in complex/matrix environments.
- Strong oral and written communication skills.