AddressThe International Regulatory Lead (Sr. Associate) is assigned to one or more Amgen products and may support an IRL or lead a program under the supervision of an experienced regulatory lead.
Execute the international regulatory strategy and regulatory plans.
Prepare supportive documentation for regulatory deliverables.
Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).
Support on the local label strategy and alignment to cCDS/reference label.
Build effective relationships and communication paths across local and functional organizations.
Enable efficiencies and seamless execution across the international countries.
STRATEGY AND EXECUTION
Provides regulatory direction/expertise on regulatory mechanisms, regulatory risks and implications and requirements to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations, compassionate use and pediatric plan) (if leading a program) .
Reviews and provides input into international regulatory document
Assists the International Regulatory Lead to support the regulatory activities and prepare supportive documentation (e.g. Clinical trial submissions, Marketing applications and lifecycle management filings) in compliance with global filing plans and local regulatory requirements. If leading a program, plans and manages regulatory submissions under general supervision.
Performs QC of regulatory documentation (e.g. briefing packages).
Supports Local Regulatory teams in triaging queries from health authorities, and where appropriate, help identify existing responses to same or similar questions, leveraging knowledge management.
Advises and supports other groups on the review of promotional and non-promotional materials, as needed.
Supports process improvement initiatives and metrics.
Manages the label submission strategy, participates in the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes (if leading a program) .
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance and obtain relevant histories, precedence and other information relating to Amgen products.
Understanding of drug development.
COMMUNICATION AND COLLABORATION
Participates as a member of the Global Regulatory Team (GRT), Evidence Generation Team (EGT), Labeling Working Group (LWG), Clinical Study Team (CST), Regional Brand Team and others, as applicable (if leading a program or to support the IRL) .
Maintains regular communications with the local teams to ensure alignment on strategy and keep the countries informed of status on the product development.
Partners with peers to ensure consistency in procedures.
Ability to understand and communicate scientific/clinical information.
BASIC QUALIFICATIONS
Master’s degree OR
Bachelor’s degree and 2 years of experience OR
Associate’s degree and 6 years of experience OR
High school diploma / GED and 8 years of experience
.
PREFERRED QUALIFICATIONS
Degree and in-depth regulatory experience and/or related to the region.
In-depth knowledge of regional countries legislation and regulations relating to medicinal products.
