Manager, Regulatory Affairs CMC

Employer
AbbVie
Location
Lake County, Illinois, USA
Posted
Mar 21, 2018
Ref
1802048
Required Education
Bachelors Degree
Position Type
Full time
The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) 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 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
Qualifications : Basic:
  • 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