CMC Regulatory Affairs Lead – Hybrid, Global Submissions

AbbVie Inc.; Chicago (IL); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Hybrid work schedule

Medical/dental/vision insurance

401(k) with company match

Job summary

AbbVie Inc. is seeking a Senior Manager Regulatory Affairs, CMC to lead regulatory strategies for biologics products and manage INDs/CTAs, amendments, and variations.

You will collaborate with product development, R&D, Operations, and Global Regulatory teams to deliver timely approvals. The role requires management of submissions, change control, and agency meetings, with a hybrid schedule (3 days in office, 2 days remote) at the Waltham, MA and Lake County, IL headquarters.

Qualifications

• Bachelor's degree in pharmacy, chemistry, biology or pharmacology, engineering or related subject. Advanced degree preferred. Certification a plus.
• 8 years’ pharmaceutical experience. Preferred 10 years including regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing.
• Experience developing and implementing successful global regulatory strategies.
• Experience working in a complex and matrix environment.
• Strong oral and written communication skills.

Responsibilities

• Prepares CMC regulatory product strategies and manages regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations.
• Analyzes and interprets information impacting regulatory decisions; seeks expert advice as required.
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
• Responds to global regulatory information requests.
• Develops strategies for CMC agency meetings and manages content for pre-meeting submissions.
• Manages products and change control, analyzes and approves manufacturing change requests.
• Represents CMC regulatory affairs on cross-functional teams to maximize chances for first pass approval.
• Stays abreast of regulatory procedures and changes; analyzes legislation and guidance.
• Develops, implements, and documents RA CMC policies and participates in internal RA initiatives.
• Represents CMC on project initiatives to drive efficiencies across the company.
• Works a hybrid schedule (3 days in office; 2 days remote) from Waltham, MA & Lake County, IL.

Skills

Regulatory strategy development

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in pharmacy/chemistry/biology/pharmacology/engineering

Job description

AbbVie Inc. is seeking a Senior Manager Regulatory Affairs, CMC to lead regulatory strategies for biologics products and manage INDs/CTAs, amendments, and variations.

You will collaborate with product development, R&D, Operations, and Global Regulatory teams to deliver timely approvals. The role requires management of submissions, change control, and agency meetings, with a hybrid schedule (3 days in office, 2 days remote) at the Waltham, MA and Lake County, IL headquarters.