Senior Manager, RA CMC

Senior Manager, RA CMC role at Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that address serious health challenges across immunology, oncology, neuroscience, and eye care. Abb Vie also offers products and services in the Allergan Aesthetics portfolio.

• Prepares CMC regulatory product strategies.
• Prepares and manages regulatory submissions, including new applications, amendments, renewals, annual reports, supplements, and variations.
• Analyzes and interprets information impacting regulatory decisions.
• Reviews and revises regulatory submissions to present data and strategy effectively.
• Responds to global regulatory information requests.
• Develops strategies for CMC agency meetings and manages preparation and content of pre‑meeting submissions.
• Manages products and change control with an understanding of regulations and company procedures, approving manufacturing change requests.
• Represents CMC regulatory affairs on product development, global regulatory product teams, and operations brand teams, negotiating to maximize first-pass approval chances.
• Stays abreast of regulatory procedures and changes, analyzing legislation, regulation, and guidance.
• Develops, implements, and documents policies and procedures; participates in internal initiatives and cross‑functional projects.

Hybrid onsite opportunity located at Abb Vie office in Lake County, IL.

• Required
  
  Education:
  
  Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering, or related subject.
• Preferred Education:
  
  Relevant advanced degree preferred; certification a plus.
• Required Experience:
  
  8 years of pharmaceutical experience.
• Preferred Experience:
  
  10 years in pharmaceutical including 5+ years in 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 matrixed environment.
• Strong oral and written communication skills.
• Higher education may compensate for years of experience.

• Base pay range: $XX - $YY per year (subject to location and experience).
• Benefits include paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k).
• Eligible for short-term and long-term incentive programs.

Abb Vie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, and serving our community.