AbbVie · 10 hours ago
Associate Director, Regulatory Affairs CMC - Hybrid Onsite
North Chicago, IL
Full-time
Hybrid
Senior Level, Lead/Staff
$138K/yr - $261K/yr
8+ years expAbbVie is dedicated to discovering and delivering innovative medicines and solutions for serious health issues. The Associate Director Regulatory Affairs CMC will work with partners to develop regulatory strategies and manage submissions, ensuring compliance and fostering relationships with regulatory agencies.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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. Serves as the point of contact for the regulatory agency meetings
Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization
Develops, implements, and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC
Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company
Trains, develops and mentors individuals; may include formal supervisory responsibilities
Qualification
Required
Bachelor's Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject
8 years pharmaceutical with at least 3 years of demonstrated leadership
Experience developing and implementing successful global regulatory strategies
Experience working with Health Authority
Experience working in a complex and matrix environment
Strong oral and written communication skills
Preferred
Relevant advanced degree preferred
Certification a plus
10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-09
2026-01-08
Morningstar.com
2026-01-08
Company data provided by crunchbase