Manager - International Regulatory Lead
Amgen · Hyderabad, India
RegulatoryFull-timeCompany career page
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What they're looking for
- Doctorate degree with 6+ years regulatory experience, or Master's with 8+ years, or Bachelor's with 10+ years
- Comprehensive understanding of regulatory principles, procedures, and international registration requirements
- Knowledge of national legislation and drug development processes relevant to medicinal products
- Strong written and oral communication skills with ability to articulate scientific and clinical information
- Negotiation and influencing skills with demonstrated ability to resolve conflicts constructively
- Cultural awareness and sensitivity for cross-border collaboration across regions and countries
What you'll be doing
- Lead development of international regulatory strategy and coordinate global regulatory planning for assigned products
- Plan and oversee regulatory submissions including clinical trials and marketing authorization applications
- Direct product labeling strategy negotiations with cross-functional teams and health authorities
- Support local regulatory teams with query triage, documentation maintenance, and agency meeting coordination
- Maintain awareness of evolving regulatory legislation, policy, and technical guidance impacting product advancement
Privacy & handoff
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