Associate Director, Regulatory Affairs CMC - Hybrid Onsite

Associate Director, Regulatory Affairs CMC – Hybrid Onsite

Base pay range: $/yr – $/yr

Abb Vie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The Associate Director, Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. This role offers the opportunity to apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables.

• Prepares CMC regulatory product strategies and manages regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations.
• Analyzes and interprets information that impacts regulatory decisions and seeks expert advice when required.
• Reviews and revises regulatory submissions to effectively present data and strategy to agencies.
• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and serves as the point of contact for regulatory agency meetings.
• Manages products and change control and approves manufacturing change requests.
• Represents CMC regulatory affairs on product development and Global Regulatory Product Teams and Operations brand teams, negotiating and influencing to maximize first‑pass approval of regulatory submissions.
• Stays abreast of regulatory procedures and changes in regulatory climate and provides analysis to the organization.
• Develops, implements, and documents policies and procedures within the regulatory affairs department and 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.

• Bachelor’s Degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related subject.
• Relevant advanced degree preferred; certification a plus.
• 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 successful global regulatory strategies and 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.

• Comprehensive package including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• Eligible to participate in short‑term and long‑term incentive programs.
• This role is an onsite hybrid opportunity based in Abb Vie’s Lake County, IL office.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.