Amgen US Regulatory Professional in Thousand Oaks, California

Sr Associate Regulatory Affairs

Amgen is seeking a Senior Associate Regulatory Affairs to work out of their Thousand Oaks, CA location. This position will report to a Director of Regulatory Affairs.

Global Regulatory Affairs provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules.

The Regulatory Professional under the direction of a Regional Regulatory Lead (RRL) will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

Additional Responsibilities of the Sr Associate Regulatory Affairs position is:

  • Assist RRL to support regional regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications (BLAs) and New Drug Applications (NDAs); advisory committee meeting preparations)

  • Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with RRL

  • Create and maintain product regulatory history documents through Insight Manager for Registrations (IMR) and appropriately archive all regulatory documents and agency communications

  • Review regional component of the Global Regulatory Plan and provide input to operational deliverablesand ensure compliance with submissions to regulatory agencies

  • Collaborate with CRO's / partners to support site initiation

  • Coordinate collection of functional documents in support of regulatory applications

  • Participate in Global Regulatory Team (GRT) to support execution of regulatory strategy

  • Coordinate Quality Check (QC) of regulatory documentation (e.g. briefing packages)

  • Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)

  • Prepare regulatory packages and cross-reference letters to support investigator initiated studies

  • Approve drug shipment for Amgen and Investigator Initiated Studies

  • Complete regulatory forms to support agency communications (e.g. FDA form 1571)

  • Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams

  • Support process improvement initiatives, standards development, and metrics

  • Assist in template development and maintenance

  • Respond to specific requests from and communicate relevant issues to GRT

  • Actively support regulatory compliance

  • Support the development and execution of GRT goals

  • GRT support - Agendas, minutes

  • Ad hoc meeting support

  • Timeline management

Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of Regulatory experience

OR

Associate's degree and 6 years of Regulatory experience

OR

High school diploma / GED and 8 years of Regulatory experience

P referred Qualifications:

  • Strong communication skills - oral and written

  • Organizational skills

  • Regulated industry, science or clinical practice experience

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.