Regulatory Affairs CMC Manager: Strategy & Submissions

AbbVie; Illinois; On-site; USD 130,000 - 180,000; Full time

Job summary

AbbVie seeks a Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) to lead regulatory strategies and submissions for complex products. You will work with internal teams and external partners to enable first-pass approvals and oversee lifecycle management across IND/CTA filings and variations.

Role requires six years of biopharmaceutical RA/CMC experience, strong writing and communication skills, and the ability to influence cross-functionally within a matrix organization.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• 6 years biopharmaceutical or related industry experience.
• Strong oral and written communication skills.

Responsibilities

• Prepares CMC regulatory product strategies with limited supervision.
• Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
• Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies under limited supervision.
• Responds to global regulatory information requests under limited supervision.
• Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages.
• Mentors others and participates in RA CMC initiatives.

Skills

CMC regulatory

Regulatory submissions

IND/CTA strategy

Cross-functional collaboration

Regulatory strategy

Education

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

Job description

AbbVie seeks a Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) to lead regulatory strategies and submissions for complex products. You will work with internal teams and external partners to enable first-pass approvals and oversee lifecycle management across IND/CTA filings and variations.

Role requires six years of biopharmaceutical RA/CMC experience, strong writing and communication skills, and the ability to influence cross-functionally within a matrix organization.