Senior Manager, CMC Regulatory Affairs - Hybrid

AbbVie; Waltham (MA); Hybrid; USD 160,000 - 210,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking a Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to collaborate with internal and external partners in delivering biologics products including mAb, ADC, and cell & gene therapies. You will develop CMC regulatory strategies to enable first-pass approvals and manage content strategy for INDs/CTAs and amendments.

You will work with Regulatory Affairs, Operations, and R&D, representing CMC in teams such as Global Regulatory Product Teams.

Qualifications

• Bachelor’s degree in pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• 8+ years pharmaceutical experience with regulatory affairs or related R&D/manufacturing roles.
• Experience developing and implementing global regulatory strategies.
• Experience working in complex, matrix environments.
• Strong oral and written communication skills.

Responsibilities

• Prepares CMC regulatory product strategies and manages submissions (new applications, amendments, renewals, variations).
• Analyses information impacting regulatory decisions and seeks expert advice.
• Reviews and revises regulatory submissions to present data and strategy clearly.
• Responds to global regulatory information requests.
• Develops strategies for CMC agency meetings and prepares pre-meeting submissions.
• Manages product changes and change control in compliance with regulations.
• Represents CMC regulatory affairs on cross-functional teams to maximize first-pass approvals.
• Keeps up-to-date with regulatory procedures and climate changes.
• Develops and documents RA CMC policies and participates in internal initiatives.

Skills

Regulatory affairs

Regulatory strategy

Cross-functional collaboration

Strong communication

Leadership

Education

Bachelor’s degree in Pharmacy or related field

Job description

AbbVie is seeking a Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to collaborate with internal and external partners in delivering biologics products including mAb, ADC, and cell & gene therapies. You will develop CMC regulatory strategies to enable first-pass approvals and manage content strategy for INDs/CTAs and amendments.

You will work with Regulatory Affairs, Operations, and R&D, representing CMC in teams such as Global Regulatory Product Teams.