Hybrid Senior Manager, CMC Regulatory Affairs - Global

AbbVie; Massachusetts; Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory strategies for biologics products. You will work with internal and external partners to craft submissions, manage amendments, and respond to information requests.

This role partners closely with product development, RA, and operations to drive first-pass approvals. The position offers a hybrid work schedule (3 in office, 2 remote) from our Waltham, MA and Lake County, IL

Qualifications

• Bachelor’s degree in pharmacy, chemistry, biology, pharmacology, engineering or a related subject.

Responsibilities

• Prepares CMC regulatory product strategies for submissions.
• Prepares and manages regulatory submissions including new applications and amendments.
• Reviews and revises regulatory submissions to present data clearly.
• Responds to global regulatory information requests.
• Develops strategies for CMC agency meetings and pre-meeting submissions.
• Manages product changes with regulatory awareness and QA oversight.
• Represents CMC regulatory affairs on cross-functional teams.
• Keeps up-to-date with regulatory changes and provides guidance.
• Develops, implements, and documents RA CMC policies and procedures.
• Hybrid schedule: 3 days in office & 2 days remote from headquarters.

Skills

Regulatory affairs

CMC

Regulatory strategy

Leadership

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Job description

AbbVie is seeking a Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory strategies for biologics products. You will work with internal and external partners to craft submissions, manage amendments, and respond to information requests.

This role partners closely with product development, RA, and operations to drive first-pass approvals. The position offers a hybrid work schedule (3 in office, 2 remote) from our Waltham, MA and Lake County, IL