Job Title:
Senior Manager, Regulatory Affairs (Gen Med / Biosimilars)
International Regulatory Lead
Job Details:
Job ID: R-221826
Location: India – Hyderabad
Work Location: On-site
Date Posted: July 29, 2025
Category: Regulatory
Company: Amgen
Group Purpose:
International Regulatory Affairs provides regulatory leadership and expertise for the development, registration, and lifecycle management of all Amgen molecules globally.
Job Summary:
The Senior Manager – International Regulatory Lead is responsible for leading regulatory strategy and compliance for one or more complex Amgen products with high impact. The role involves optimizing product development, ensuring regulatory compliance, and collaborating across global and regional teams.
Key Responsibilities:
Strategy & Execution
Advise global teams on regulatory implications for clinical development and marketing applications
Provide regulatory direction on mechanisms to optimize product development (e.g., orphan drug designation, expedited pathways)
Plan and execute regulatory submissions including clinical trial applications and marketing authorizations
Develop and communicate international regulatory strategies and contingency plans
Maintain CTA/MA documentation and support regulatory filings, including authoring and redaction as needed
Lead internal discussions for agency meetings and communicate outcomes
Direct international product labeling strategy in collaboration with the Labeling Working Group
Manage label submission strategy and negotiations with cross-functional teams
Support local regulatory teams with health authority queries and knowledge management
Advise on review of promotional and non-promotional materials
Participate in process improvement and metrics initiatives
Communication & Collaboration
Actively participate in Global Regulatory Team (GRT), Evidence Generation Team (EGT), Labeling Working Group (LWG), Clinical Study Team (CST), and other cross-functional teams
Share regulatory insights and advice on international considerations with global teams
Provide guidance on local label deviation requests
Partner with peers to align on product strategy and submission timelines
Maintain communication with local teams to ensure alignment and inform on product status
Build effective relationships across global and local regulatory functions
Regulatory Research
Stay updated on new and evolving legislation, policies, and regulatory guidance
Conduct regulatory research on precedents and relevant histories to support product advancement
Mentoring
Mentor and advise junior International Regulatory Leads
Knowledge & Skills:
Scientific & Technical
Strong knowledge of regulatory principles, policies, procedures, and SOPs
Comprehensive understanding of regulatory activities and their impact
Familiarity with national legislation and regulations for medicinal products
Awareness of registration procedures for CTAs, MAs, and lifecycle management
Understanding of drug development processes
Ability to anticipate agency questions and prepare responses
Other Skills
Excellent teamwork and communication (oral and written)
Strong negotiation and influencing skills
Ability to understand and communicate scientific and clinical information
Conflict resolution skills and ability to guide toward beneficial outcomes
Cultural sensitivity for working across regions and countries
Education & Experience:
Doctorate degree
OR
Master’s degree (scientific field) with 6 years of directly related experience
OR
Bachelor’s degree (scientific field) with 8 years of directly related experience
Preferred Experience:
In-depth regulatory experience related to the region
Detailed knowledge of legislation and regulations across regional countries for medicinal products
Apply Now
For more details and application, visit: Amgen Careers
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer. We provide reasonable accommodations to individuals with disabilities to participate in the job application or interview process, perform essential functions, and receive benefits and privileges of employment.
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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