Regulatory Affairs Manager – International Regulatory Lead (IRL) at Amgen-Apply before 30th July 2025

About Amgen

At Amgen, we harness the power of biology and advanced technology to combat the world’s most challenging diseases. With over four decades of biotech leadership, we remain at the forefront of scientific innovation to enhance and extend the lives of millions of patients across the globe.

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Role Overview

As a Regulatory Affairs Manager – International Regulatory Lead (IRL), you will be responsible for developing and executing regulatory strategies to support global product development, marketing applications, and lifecycle management across International markets. This is a cross-functional leadership role requiring strategic regulatory expertise and global collaboration.

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Key Responsibilities

• Provide regulatory leadership for Amgen’s products in international markets.

• Collaborate with global and regional teams to develop effective regulatory strategies for product development and registration.

• Advise cross-functional teams on international regulatory pathways (e.g., Orphan Drug, Fast Track, Reliance Mechanisms, Pediatric Plans).

• Plan, support, and review regulatory submissions, including CTAs and marketing applications.

• Author/redact relevant submission documents (excluding CMC).

• Lead international labelling strategy and participate in global label negotiation processes.

• Support local teams in responding to health authority queries and leverage global knowledge repositories.

• Represent the International Regulatory function on Global Regulatory Teams (GRT) and other cross-functional groups.

• Monitor and share updates on regulatory legislation and guidelines relevant to Amgen’s product portfolio.

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Candidate Profile

Educational Qualifications:
One of the following:

• Doctorate degree

• Master’s degree with 3+ years of regional regulatory experience

• Bachelor’s degree with 5+ years of regional regulatory experience

• Associate degree with 10+ years of experience

• High school diploma/GED with 12+ years of relevant experience

Technical Competencies:

• In-depth understanding of international regulatory frameworks and submission pathways

• Experience with clinical trial applications, product variations, and labelling activities

• Knowledge of biotechnology or oncology products preferred

• Strong regulatory research, documentation, and compliance capabilities

Soft Skills:

• Excellent verbal and written communication

• Strong organizational and multitasking skills

• Collaborative mindset with global, cross-cultural awareness

• Initiative-driven with sound negotiation and influencing skills

• Ability to translate complex scientific data into clear regulatory narratives

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Position Details

• Industry Type: Pharma / Healthcare / Clinical Research

• Functional Area: Regulatory Affairs

• Experience: 3+ Years

• Job Location: Hyderabad

• Job ID: R-215832

• Last Date to Apply: 30th July 2025

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How to Apply

To apply, visit Amgen Careers and search for Job ID: R-215832, or submit your updated resume through your professional network platform.

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