CMC Regulatory Affairs Leader - Strategy & Submissions

AbbVie; Illinois; On-site; USD 140,000 - 190,000; 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, Chemistry, Manufacturing and Controls (CMC) to lead regulatory strategies for product submissions, including INDs/CTAs and variations, and to serve as a strategic liaison with authorities.

You will collaborate with global teams, manage submissions, influence decisions, and mentor staff while navigating complex regulatory landscapes across multiple programs.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• Strong oral and written communication skills.
• Experience developing and implementing global regulatory strategies and working with Health Authorities.

Responsibilities

• Prepares CMC regulatory product strategies and submissions (INDs/CTAs, amendments, variations, annual reports).
• Represents CMC regulatory affairs on cross-functional teams and with regulatory agencies.
• Reviews and revises regulatory submissions to present data and strategy effectively.
• Leads preparation for agency meetings and manages regulatory change control processes.
• Mentors staff and fosters internal RA CMC initiatives.

Skills

Regulatory leadership

Regulatory strategy

Communication skills

Education

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

Job description

AbbVie in the United States is seeking an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory strategies for product submissions, including INDs/CTAs and variations, and to serve as a strategic liaison with authorities.

You will collaborate with global teams, manage submissions, influence decisions, and mentor staff while navigating complex regulatory landscapes across multiple programs.