Senior CMC Regulatory Affairs Lead – Hybrid

AbbVie; Waltham (MA); Hybrid; USD 125,000 - 237,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie Inc. in Waltham, MA is seeking a Senior Manager Regulatory Affairs (CMC) to develop and manage regulatory strategies for CMC submissions, including INDs/CTAs, amendments, and variations. You will collaborate with product development, RA, and operations to ensure first-pass approvals.

The role requires 8–10 years in pharma regulatory affairs, strong communication, and experience with global submissions. Hybrid work is offered, with a base in Massachusetts or Illinois locations.

Qualifications

• Bachelor’s degree in pharmacy, chemistry, biology or pharmacology, engineering or related field.
• 8 years of pharmaceutical experience; 10 years preferred including 5+ years in regulatory affairs.
• Experience developing global regulatory strategies.
• Strong oral and written communication skills.

Responsibilities

• Prepares CMC regulatory product strategies and submissions.
• Analyzes information impacting regulatory decisions and seeks expert advice.
• Reviews and revises regulatory submissions for data presentation.
• Responds to global regulatory information requests.
• Develops strategies for CMC agency meetings and prepares pre-meeting submissions.
• Manages product change control and manufacturing change requests.
• Represents CMC RA on cross-functional teams to maximize first-pass approvals.
• Stays updated on regulatory changes and provides analysis.
• Develops and documents RA CMC policies and participates in cross-functional initiatives.
• Hybrid work schedule: 3 days in office, 2 days remote from Waltham, MA.

Skills

Strong oral and written communication

Education

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

Advanced degree preferred

Certification a plus

Job description

AbbVie Inc. in Waltham, MA is seeking a Senior Manager Regulatory Affairs (CMC) to develop and manage regulatory strategies for CMC submissions, including INDs/CTAs, amendments, and variations. You will collaborate with product development, RA, and operations to ensure first-pass approvals.

The role requires 8–10 years in pharma regulatory affairs, strong communication, and experience with global submissions. Hybrid work is offered, with a base in Massachusetts or Illinois locations.