Manager, Regulatory Affairs CMC

Employer
AbbVie
Location
Lake County, IL, US
Posted
Nov 29, 2018
Ref
1808825
Required Education
Bachelors Degree
Position Type
Full time
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