Manager, Regulatory Affairs CMC

Lake County, IL, US
Sep 28, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) Combination Products & Medical Devices combines scientific, regulatory & business issues to enable products that are developed, manufactured or distributed to meet required legislation. Provides support for the regulatory department to ensure efficient & compliant business processes & environment. Develops & manages content strategy for regulatory submissions, including new market applications, supplements & variations. Prepares CMC regulatory strategies that enable first pass approvals under management supervision; builds & maintains relationships within the regulatory affairs functional areas, Operations & Research & Development (R&D). Manages products & change control in compliance with regulations, company policies & procedures. Serves as liaison with FDA. Represents CMC regulatory affairs on teams such as the product development & Operations brand teams to negotiate, influence & provide strategic advice.

Key Responsibilities Include:

  • 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 submission
  • 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

  • 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