AbbVie Pharmacyclics Sr. Manager, CMC - Regulatory Affairs in Sunnyvale, California

Sr. Manager, CMC - Regulatory Affairs

Location: Sunnyvale, CA

# of Openings: 1

Description

Sr. Manager, CMC – Regulatory Affairs

Location:Sunnyvale, CA

# of Openings: 1

Description

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.

Qualifications:

· 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