CMC Regulatory Affairs Manager – Biologics Strategy Lead

Regulatory Jobs; Irvine (CA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

AbbVie is seeking a Manager of Regulatory Affairs for CMC (Biologics Product Lead) to collaborate with internal and external partners and deliver regulatory strategies for INDs/CTAs and life-cycle management. The role requires preparing submissions and navigating agency interactions with limited supervision.

The position involves building relationships across RA CMC, R&D, and Operations, mentoring peers, and supporting cross-functional teams in a hybrid work environment with possible offices in

Qualifications

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

Responsibilities

• Prepares CMC regulatory product strategies with limited supervision.
• Prepares regulatory submissions, including IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
• Analyzes information impacting regulatory decisions and seeks expert advice as required.
• Reviews and revises submission documentation to present data and strategy to agencies.

Skills

Regulatory strategy

CMC submissions

Cross-functional collaboration

Mentoring

Education

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

Advanced degree preferred

Job description

AbbVie is seeking a Manager of Regulatory Affairs for CMC (Biologics Product Lead) to collaborate with internal and external partners and deliver regulatory strategies for INDs/CTAs and life-cycle management. The role requires preparing submissions and navigating agency interactions with limited supervision.

The position involves building relationships across RA CMC, R&D, and Operations, mentoring peers, and supporting cross-functional teams in a hybrid work environment with possible offices in