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
Bachelor's degree and 2 years of Regulatory experience
Associate's degree and 6 years of Regulatory experience
High school diploma / GED and 8 years of Regulatory experience
P referred Qualifications:
Strong communication skills - oral and written
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.