Senior CMC Regulatory Affairs Lead - Global Submissions

AbbVie; North Chicago (IL); Hybrid; USD 125,000 - 237,000; Full time

Benefits offered by this job

Paid time off

401(k) plan

Comprehensive benefits

Job summary

AbbVie Inc. in the United States seeks a Senior Manager Regulatory Affairs (CMC) to lead regulatory initiatives for chemistry, manufacturing and controls, including biologics programs.

You will coordinate with global teams and external partners to craft submissions and support first-pass approvals. The role supports INDs/CTAs, variations and annual reports with a hybrid schedule (3 days in office, 2 days remote) from the Waltham, MA and Lake County, IL headquarters, offering a comprehensive

Qualifications

• Bachelor’s degree in pharmacy, chemistry, biology, pharmacology or related subject
• 8 years’ pharmaceutical experience
• 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing
• Strong oral and written communication skills

Responsibilities

• Prepares CMC regulatory product strategies and submissions including new applications, amendments, renewals and variations
• Analyzes information impacting regulatory decisions and seeks expert advice when needed
• 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 line with regulations and company policies
• Represents CMC RA on cross-functional teams to maximize chances for first-pass approvals
• Keeps up-to-date with regulatory procedures and changes, providing analysis to the organization
• Develops, implements and documents RA policy/procedures; collaborates across functions to drive efficiencies
• Hybrid work schedule: 3 days in office, 2 days remote from Waltham, MA and Lake County, IL headquarters

Job description

AbbVie Inc. in the United States seeks a Senior Manager Regulatory Affairs (CMC) to lead regulatory initiatives for chemistry, manufacturing and controls, including biologics programs.

You will coordinate with global teams and external partners to craft submissions and support first-pass approvals. The role supports INDs/CTAs, variations and annual reports with a hybrid schedule (3 days in office, 2 days remote) from the Waltham, MA and Lake County, IL headquarters, offering a comprehensive