Sr Mgr Regulatory Affairs

Amgen · Hyderabad, India

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RegulatoryFull-timeCompany career page

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Role summary

Senior Manager in Regulatory Affairs leading international product strategies for complex pharmaceutical and biosimilar programs at Amgen. Oversees regulatory compliance, manages global submissions, and coordinates cross-functional teams across multiple regions to ensure adherence to regulatory requirements and optimize product development.

What they're looking for

Doctorate OR Master's degree in scientific field with 6+ years regulatory experience OR Bachelor's in scientific field with 8+ years regulatory experience
Knowledge of regulatory principles, policies, procedures and SOPs
Comprehensive understanding of international regulatory environment and registration procedures for CTAs and MAs
Strong written and oral communication skills with ability to convey scientific/clinical information
Negotiation and influencing skills with demonstrated ability to resolve conflicts
Cultural awareness and sensitivity across regional and international borders

What you'll be doing

Lead one or more Amgen products with complex programs; develop international regulatory strategy and contribute to global regulatory plans
Plan regulatory submissions including clinical trials and marketing authorization applications with minimal supervision
Direct product label development collaborating with cross-functional teams; manage international label submission strategy and negotiate with stakeholders
Advise Global teams on regulatory implications and lead internal Agency meeting discussions in accordance with strategy
Mentor junior International Regulatory Leads; maintain awareness of developing legislation and regulatory policy relevant to products

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Date posted16 days ago

Last source check1 day ago

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