CMC Regulatory Affairs: Associate Director — Lead Submissions

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

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in the United States is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for drug products. You will collaborate with internal teams and external partners, negotiating with agencies to enable first-pass approvals and driving strategic advisory within CMC on product development, regulatory submissions, and ongoing compliance.

The role requires strong leadership, extensive experience in regulatory affairs, and the ability to navigate

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related subject.
• 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.

Responsibilities

• Prepares CMC regulatory product strategies and manages submissions, renewals, and amendments.
• Analyzes information impacting regulatory decisions and seeks expert advice as needed.
• Reviews and revises regulatory submissions to present data effectively to agencies.
• Leads meetings with regulatory agencies and prepares pre-meeting submissions.
• Manages products and change control with understanding of regulations and company policies.

Skills

Regulatory strategy

Regulatory submissions

Leadership

Communication skills

Education

Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject

Advanced degree preferred

Job description

AbbVie in the United States is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for drug products. You will collaborate with internal teams and external partners, negotiating with agencies to enable first-pass approvals and driving strategic advisory within CMC on product development, regulatory submissions, and ongoing compliance.

The role requires strong leadership, extensive experience in regulatory affairs, and the ability to navigate