CMC Regulatory Strategy Lead

BioSpace; Irvine (CA); On-site; USD 160,000 - 230,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to drive regulatory strategy for CMC, manage submissions, and liaise with regulatory agencies. You will lead cross-functional teams, develop content for INDs/CTAs and amendments, and ensure alignment with product development goals.

The role requires deep regulatory expertise, strong communication, and proven leadership in a matrix environment.

Qualifications

• Bachelor's degree in one of the sciences or engineering fields as required.
• Advanced degree preferred; certification a plus.

Responsibilities

• Prepare CMC regulatory product strategies and submissions (INDs/CTAs, amendments, renewals).
• Build and manage content strategy for regulatory submissions.
• Serve as liaison with regulatory agencies (e.g., FDA).
• Lead or contribute to RA CMC teams to drive first-pass approvals.
• Develop and implement regulatory policies within RA CMC.

Skills

Regulatory strategy

Global regulatory

Regulatory communication

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related subject

Advanced degree preferred

Job description

AbbVie is seeking an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to drive regulatory strategy for CMC, manage submissions, and liaise with regulatory agencies. You will lead cross-functional teams, develop content for INDs/CTAs and amendments, and ensure alignment with product development goals.

The role requires deep regulatory expertise, strong communication, and proven leadership in a matrix environment.