AbbVie Pharmacyclics Sr. Manager, CMC - Regulatory Affairs in Sunnyvale, California
Sr. Manager, CMC - Regulatory Affairs
Location: Sunnyvale, CA
# of Openings: 1
Sr. Manager, CMC – Regulatory Affairs
# of Openings: 1
General Position Summary/Purpose:
Prepare and review CMC regulatory documentation for company products.
Key Accountabilities/Core Job Responsibilities:
· Assemble, lead and coordinate compilation of CMC section of regulatory submissions.
· Coordinate, write, and compile CMC document packages and investigational drug shipment related activities for drug manufacturing acc. to regulations/guidelines and company SOPs.
· Represent Regulatory Affairs CMC group at project team meetings and coordinate regulatory workflow between departments and CROs.
· Coordinate drafting of responses to regulatory questions in timely manner; assist in review of change controls and provides regulatory impact assessment; escalate issues, as needed.
· Perform other duties, as assigned.
· M.S. in Chemistry, Pharmaceutical Chemistry or Biochemistry
· At least 2 years in position offered or in a regulatory affairs position
· FDA drug regulations and guidelines (CFR 21 parts 312 and 314)
· Develop RA strategy and positioning to support new products
· Track regulatory approvals for product launches
· Develop RA department standards and SOPS
· Provide technical guidance on review and evaluation of regulatory submissions
· Electronic document management systems and submissions in eCTD format
· Project management for global regulatory submissions
· CAPA and cGMP
Hiring Requirements: Background & Reference Checks
Equal Opportunity Employer Minorities/Women/Veterans/Disabled