Senior Manager, CMC Regulatory Strategy & Submissions

AbbVie; Illinois; Hybrid; USD 135,000 - 195,000; Full time

Job summary

AbbVie is seeking aSenior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory product strategies for CMC, including INDs/CTAs and amendments. You will manage regulatory submissions and amendments, collaborate with Global Regulatory Product Teams, Operations, and R&D, and provide strategic advice to ensure first-pass approvals.

The role requires strong communication, experience in complex matrix environments, and 8+ years in pharmaceutical regulatory

Qualifications

• Bachelor's degree in pharmacy, chemistry, biology, pharmacology, engineering or related subject.
• Advanced degree preferred. Certification a plus.

Responsibilities

• Prepares CMC regulatory product strategies and manages regulatory submissions, including new applications/amendments, renewals and variations.
• Responds to regulatory information requests and maintains data strategy for submissions.
• Reviews and revises regulatory submissions to present data and strategy effectively to regulators.
• Stays updated on regulatory procedures and changes and provides analysis to the organization.

Skills

Regulatory strategy experience

Communication skills

Matrix environment experience

Pharmaceutical industry experience

Education

Bachelor's degree in pharmacy, chemistry, biology or pharmacology, engineering or related subject

Advanced degree preferred

Job description

AbbVie is seeking aSenior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory product strategies for CMC, including INDs/CTAs and amendments. You will manage regulatory submissions and amendments, collaborate with Global Regulatory Product Teams, Operations, and R&D, and provide strategic advice to ensure first-pass approvals.

The role requires strong communication, experience in complex matrix environments, and 8+ years in pharmaceutical regulatory