Regulatory Affairs Mgr
Amgen · Hyderabad, India
RegulatoryFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Manager overseeing international regulatory strategy and product approvals for Amgen's global portfolio. This role collaborates with global and local teams to optimize clinical development and regulatory submissions across international markets.
What they're looking for
- Doctorate degree, or Master's plus 3 years regulatory experience, or Bachelor's plus 5 years experience
- Knowledge of international clinical trial and marketing authorization regulatory environments
- Experience with biotechnology or oncology product regulations and labeling
- Understanding of regulatory principles and cross-functional impact assessment
- Familiarity with registration procedures across multiple international countries
- Strong written and oral communication skills
- Ability to work across global, virtual, and culturally diverse teams
What you'll be doing
- Advise global teams on regulatory requirements and implications for clinical development and marketing applications
- Plan and manage international regulatory submissions for clinical trials, marketing authorizations, and lifecycle management
- Develop and communicate international regulatory strategy documents including filing plans and risk assessments
- Direct label submission strategy development and lead cross-functional negotiation activities
- Support local teams in responding to health authority queries and leverage regulatory precedence knowledge
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.