Job Title: Manager – International Regulatory Lead (IRL)
Role Name: Manager – International Regulatory Lead
Department: International Regulatory Team, Global Regulatory Affairs
GCF Level: 5A
Location: India – Hyderabad
Work Location Type: On Site
Date Posted: Not specified, assumed recent
Category: Regulatory
About Amgen
Amgen is a global biotechnology leader dedicated to using science and technology to combat serious illnesses. With over 40 years of innovation, Amgen continues to pioneer new approaches to drug development, leveraging biology and human genetics to deliver life-changing therapies to millions of patients worldwide.
About the Role
The Manager – International Regulatory Lead (IRL) will provide regulatory leadership and strategic support for one or more Amgen products in international markets. The role focuses on optimizing product development, regulatory approvals, and lifecycle management in collaboration with global and local regulatory functions.
Key Responsibilities
Strategy & Regulatory Support
Advise global teams on international regulatory requirements and implications.
Provide strategic input on regulatory mechanisms (e.g., FIH studies, Orphan Drug, expedited pathways, reliance mechanisms, pediatric plans).
Plan regulatory submissions (Clinical Trials, Marketing Applications, lifecycle updates) under general supervision.
Develop international regulatory strategy documents and risk-based plans.
Maintain regulatory documentation (excluding CMC); may author/redact documents.
Labeling and Submissions
Manage international label submission strategy and cross-functional negotiation.
Handle label deviation requests and oversee outcomes.
Support local teams in managing health authority queries through knowledge sharing.
Cross-Functional Collaboration
Participate in teams such as GRT, clinical, and labeling workstreams.
Maintain communication with local teams to align on product strategy and updates.
Build strong communication pathways across global, regional, and local regulatory teams.
Regulatory Intelligence & Research
Stay updated on regulatory laws, policy changes, and guidance.
Perform regulatory research and analysis for product strategy and advancement.
Basic Qualifications & Experience
Minimum (any one of the following):
Doctorate degree
Master’s degree + 3 years of relevant regional regulatory experience
Bachelor’s degree + 5 years
Associate degree + 10 years
High school diploma / GED + 12 years
Functional Skills
Must-Have Skills:
Experience with international regulatory submissions, including CTAs, variations, and labeling for biotech/oncology.
Solid understanding of regulatory principles and cross-functional impact.
Familiarity with registration procedures in international countries.
Good-to-Have Skills:
Conflict resolution and action planning abilities.
Cultural sensitivity in global regulatory settings.
Soft Skills
Strong written and verbal communication.
Ability to explain and discuss scientific and clinical data.
Team-oriented with global collaboration experience.
Self-motivated, proactive, and well-organized.
Multitasking and time management proficiency.
Effective negotiation and influencing capabilities.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer. The company is committed to accommodating individuals with disabilities through all stages of the employment process, including application and job performance.
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