Job Title: Sr Manager – International Regulatory Lead
Location: India – Hyderabad
Work Location Type: On Site
Job ID: R-208840
Date Posted: April 1, 2025
Category: Regulatory
About Amgen
Amgen is a global biotechnology company focused on using biological and technological innovations to fight serious diseases. With over 40 years of experience, Amgen continues to develop and deliver medicines that improve lives.
About the Role
The Senior Manager – International Regulatory Lead oversees regulatory compliance for assigned products within Amgen's portfolio, particularly those with complex strategies and high impact. This role develops international regulatory strategies, ensures compliance, supports label strategies, and works closely with global and local teams for seamless execution.
Group Purpose
International Regulatory Affairs provides leadership and expertise for the development, registration, and lifecycle management of Amgen’s global products.
Key Responsibilities
Strategy and Execution
Provide expert regulatory direction for international clinical development and marketing plans.
Lead regulatory submissions: Clinical Trials (CTAs), Marketing Authorizations (MAs), and lifecycle management activities.
Develop international regulatory strategy documents and filing plans.
Maintain and support CTA/MA documentation, author/redact documents.
Lead internal Agency meeting discussions and follow-up actions.
Direct the development of international product labels and lead negotiation efforts.
Support local teams in responding to regulatory authority queries.
Review promotional and non-promotional materials as needed.
Lead or support regulatory process improvement initiatives.
Communication and Collaboration
Participate in cross-functional teams such as GRT, EGT, LWG, and CST.
Share regulatory updates with global teams and contribute to decision-making.
Align global and local regulatory teams on strategy and timelines.
Promote consistent regulatory procedures and collaboration.
Regulatory Research
Stay informed on changes in international regulatory legislation and guidance.
Perform regulatory research to inform product advancement strategies.
Mentoring
Mentor or advise junior regulatory professionals.
Knowledge and Skills
Scientific and Technical
Strong foundation in regulatory principles and procedures.
Comprehensive understanding of CTA, MA, and lifecycle management challenges.
Knowledge of local and international regulatory environments.
Familiarity with drug development stages and regulatory implications.
Ability to anticipate regulatory agency expectations and craft appropriate responses.
Other Skills
Effective teamwork and interpersonal skills.
Strong written and verbal communication.
Negotiation and influence abilities.
Cross-cultural awareness and adaptability.
Conflict resolution and problem-solving capabilities.
Education & Experience Requirements
Minimum (any one of the following):
Doctorate degree + 2 years of directly related experience
Master’s degree + 6 years
Bachelor’s degree + 8 years
Associate’s degree + 10 years
High school diploma / GED + 12 years
Preferred:
Degree with in-depth regulatory experience.
Strong knowledge of regional regulations for medicinal products.
Equal Opportunity Statement
Amgen is committed to equal opportunity employment. Individuals with disabilities may request reasonable accommodation during any phase of the application process.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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