CMC Regulatory Strategy Lead – Associate Director

AbbVie; Massachusetts; On-site; USD 150,000 - 210,000; Full time

Job summary

AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies for chemistry, manufacturing and controls across products. The role requires collaboration with global teams to prepare regulatory submissions and to represent CMC in agency interactions.

The candidate will manage complex regulatory submissions, drive strategy development, and contribute to ongoing improvements in regulatory processes.

Qualifications

• Bachelor’s degree required in a relevant field (Pharmacy, Chemistry, Biology, Pharmacology, Engineering).
• 8 years pharmaceutical experience with at least 3 years in leadership.
• Experience developing global regulatory strategies and working with Health Authorities.

Responsibilities

• Prepares CMC regulatory product strategies and manages submissions and amendments.
• Analyzes regulatory information and seeks expert advice for strategies and submissions.
• Reviews and revises submissions to present data and strategy to agencies clearly.
• Develops CMC meeting strategies and prepares pre-meeting submissions; acts as liaison.
• Manages change control with understanding of regulations and company policies.
• Mentors team members and may have supervisory responsibilities.

Skills

Regulatory strategy

CMC regulatory knowledge

Leadership

Communication

Education

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

Advanced degree preferred

Job description

AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies for chemistry, manufacturing and controls across products. The role requires collaboration with global teams to prepare regulatory submissions and to represent CMC in agency interactions.

The candidate will manage complex regulatory submissions, drive strategy development, and contribute to ongoing improvements in regulatory processes.