Associate Director, CMC Regulatory Strategy & Submissions

Allergan; Waltham (MA); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in Massachusetts seeks an Associate Director Regulatory Affairs (CMC) to lead strategy and submissions for regulatory approvals and changes. You will collaborate with Product Development, R&D and Operations to guide global CMC programs and liaise with health authorities.

The role requires extensive regulatory experience, leadership, and strong communication skills to navigate complex environments and drive first-pass approvals.

Qualifications

• Bachelor’s degree in a relevant science or engineering field.
• 8 years pharmaceutical experience with at least 3 years of leadership.
• 10 years pharmaceutical experience with 5+ years in regulatory affairs or in Discovery/R&D/Manufacturing.

Responsibilities

• Prepares CMC regulatory product strategies and submissions including new applications, amendments, renewals and variations.
• Analyzes information impacting regulatory decisions and seeks expert advice as needed.
• Reviews regulatory submissions to present data and strategy to agencies.
• Develops CMC meeting strategies and manages pre-meeting submissions and agency interactions.
• Manages change control and approves manufacturing change requests.
• Leads collaboration with product development and Global Regulatory product teams to optimize approvals.
• Keeps up to date with regulatory procedures and guidance for decision making.
• Develops and documents RA CMC policies and leads internal RA initiatives.
• Represents CMC RA in cross-functional project teams to improve efficiency.

Skills

CMC strategy

Regulatory submissions

FDA liaison

Leadership

Education

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

Advanced degree preferred

Job description

AbbVie in Massachusetts seeks an Associate Director Regulatory Affairs (CMC) to lead strategy and submissions for regulatory approvals and changes. You will collaborate with Product Development, R&D and Operations to guide global CMC programs and liaise with health authorities.

The role requires extensive regulatory experience, leadership, and strong communication skills to navigate complex environments and drive first-pass approvals.