AbbVie Manager, Regulatory Affairs CMC in Lake County, Illinois

Manager, Regulatory Affairs CMC

USA, Illinois, Lake County

2 additional locations

USA, IllinoisUSA

Regulatory Affairs

Requisition #1808825

Key Responsibilities Includes:

  • Identifies and collects data needed and prepares CMC regulatory product strategies under limited supervision. Seeks expert advice and technical support as required for strategies and submissions

  • Prepares regulatory applications, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision.

  • Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests.

  • Develops strategies for CMC meetings, manage preparation for agency meetings and manages content of pre-meeting submissions

  • Regularly informs regulatory management of important timely issues

  • Trains, develops and mentors individuals; may include formal supervisory responsibilities

  • Develops and implements policies and procedures within the regulatory affairs department

  • Analyzes legislation, regulation and guidance and provides analysis to the organization

  • ? Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval or regulatory submissions

  • Supports combination products and medical devices including design control and change management activities

MULTIPLE POSITIONS AVAILABLE

POSITION MAY BE FILLED AT LEVEL COMMENSURATE WITH EXPERIENCE

  • Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject

  • Preferred Education: Relevant advanced degree preferred

  • Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management

  • Experience working in a complex and matrix environment

  • Strong communication skills, both oral and written

  • Preferred Experience: 5 years’ experience in Discovery, R&D, or Manufacturing. 5 years’ experience in Regulatory Affairs (pharmaceutical/medical device/combination product)

  • Note: Higher education may compensate for years of experience

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Additional Information

  • Travel: No

  • Job Type: Experienced

  • Schedule: Full-time