Strategic RA CMC Associate Director

AbbVie; North Chicago (IL); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Long-term incentive programs

Comprehensive benefits including PTO/4

Job summary

AbbVie in North Chicago, IL seeks an Associate Director Regulatory Affairs, CMC to lead regulatory strategies for chemistry, manufacturing and controls and to coordinate submissions (INDs, CTAs, variations) with global teams.

You will influence FDA interactions, manage submissions, and mentor RA staff. Requires 8+ years in pharma, 3+ years leadership, strong communication, and experience in global regulatory strategies.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• 8 years pharmaceutical experience with at least 3 years of demonstrated leadership.
• 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing.
• Experience developing and implementing global regulatory strategies; experience working with Health Authority.
• Experience working in a complex and matrix environment.
• Strong oral and written communication skills.
• Higher education may compensate for years of experience.

Responsibilities

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions; seeks expert advice and technical support as required for strategies and submissions.
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
• Represents CMC regulatory affairs on teams such as product development, Global Regulatory Product Teams and Operations brand teams to maximize chances for first pass approval.
• Stays abreast of regulatory procedures and changes in regulatory climate; analyzes legislation, regulation and guidance.
• Develops, implements, and documents policies and procedures within the regulatory affairs department.

Job description

AbbVie in North Chicago, IL seeks an Associate Director Regulatory Affairs, CMC to lead regulatory strategies for chemistry, manufacturing and controls and to coordinate submissions (INDs, CTAs, variations) with global teams.

You will influence FDA interactions, manage submissions, and mentor RA staff. Requires 8+ years in pharma, 3+ years leadership, strong communication, and experience in global regulatory strategies.