Senior CMC Regulatory Affairs Lead — First-Pass Strategy

AbbVie; Waltham (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions across INDs/CTAs and amendments. You will partner with R&D, Operations and product teams to ensure timely, compliant filings and first-pass approvals, while guiding cross-functional teams through evolving regulatory landscapes.

The role emphasizes strategic liaison with agencies like the FDA, strong communication skills, and leadership in a matrix environment.

Qualifications

• Bachelor’s degree in a relevant scientific field (Pharmacy, Chemistry, Biology, Pharmacology, Engineering) required.
• Advanced degree preferred; certification a plus.

Responsibilities

• Prepares CMC regulatory product strategies and manages regulatory submissions (new applications, amendments, renewals, annual reports, supplements, variations).
• Analyzes information impacting regulatory decisions and seeks expert advice as needed.
• Reviews and revises regulatory submissions to present data and strategy to agencies.
• Leads strategy for CMC agency meetings and prepares pre-meeting submissions; acts as primary contact with regulatory agencies.
• Manages products and change control with understanding of regulations and company policies; approves manufacturing change requests.
• Represents CMC regulatory affairs on cross-functional teams to maximize chances for first-pass approvals.
• Stays updated on regulatory procedures and changes; analyzes legislation and guidance.
• Develops and documents RA CMC policies, initiatives and processes; mentors team members; may have supervisory responsibilities.

Skills

Regulatory strategy

CMC knowledge

Leadership

Communication

Regulatory submissions

Education

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

Job description

AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions across INDs/CTAs and amendments. You will partner with R&D, Operations and product teams to ensure timely, compliant filings and first-pass approvals, while guiding cross-functional teams through evolving regulatory landscapes.

The role emphasizes strategic liaison with agencies like the FDA, strong communication skills, and leadership in a matrix environment.