Job Title: Manager – International Regulatory Lead (IRL)
Location: India – Hyderabad (On Site)
Job ID: R-211202
Date Posted: April 4, 2025
Category: Regulatory
Department: International Regulatory Team, Global Regulatory Affairs
Role GCF: 5A
Company Overview
Amgen is a pioneer in biotechnology, dedicated to using science and innovation to improve lives. With 40+ years of industry leadership, Amgen focuses on discovering and delivering innovative medicines to combat serious illnesses.
Job Summary
The International Regulatory Lead (IRL) Manager is responsible for providing regulatory strategy and support for Amgen products across international markets. This role involves collaboration with global, regional, and local teams to guide product development, streamline regulatory approvals, and manage life cycle activities in alignment with evolving international regulations.
Key Responsibilities
Provide strategic regulatory advice for international product development, clinical trials, and marketing applications
Develop and maintain international regulatory strategies, including risk assessment and contingency planning
Lead label submission strategies and coordinate negotiations with cross-functional teams
Author and maintain regulatory documentation (excluding CMC content)
Support local regulatory teams in addressing Health Authority queries
Participate in Global Regulatory Teams (GRT) and contribute to clinical and labeling strategy discussions
Conduct regulatory research and maintain awareness of changing international legislation
Foster effective cross-functional and cross-border collaboration
Basic Qualifications
Doctorate degree OR
Master's degree with 10+ years of relevant regional regulatory experience OR
Bachelor's degree with 12+ years of relevant regional regulatory experience
Must-Have Skills
In-depth knowledge of international regulatory frameworks for clinical trial applications, marketing authorizations, and labeling
Strong understanding of regulatory principles and their implications for drug development
Familiarity with registration procedures in global markets
Good-to-Have Skills
Conflict resolution and outcome-oriented decision-making
Cultural awareness and sensitivity for global collaboration
Soft Skills
Excellent verbal and written communication
Strong organizational and planning abilities
Effective team player with influencing and negotiation skills
Ability to manage multiple priorities and function in a matrixed environment
Self-motivated with a high level of initiative
Equal Opportunity Statement
Amgen is committed to equal employment opportunities and provides reasonable accommodations for individuals with disabilities in the hiring process and throughout employment.
How to Apply
Visit: careers.amgen.com
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