Global Regulatory Writing Manager
Amgen · Hyderabad, India
RegulatoryFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Amgen seeks a regulatory writing manager in Hyderabad to author clinical submission documents, lead cross-functional product teams, and mentor junior writers. The role requires managing regulatory writing activities for drug and biologics applications while maintaining stakeholder relationships.
What they're looking for
- Doctorate degree, or Master's with 4-6 years regulatory writing experience
- Bachelor's with 6-8 years experience, or Diploma with 10-12 years experience
- Advanced proficiency in Microsoft Office and scientific/technical writing
- Strong knowledge of ICH, GCP guidance, and clinical development processes
- Excellent written and oral communication with attention to detail
- Project management skills and ability to lead cross-functional teams
What you'll be doing
- Author regulatory documents including clinical study reports, protocols, and eCTD submissions
- Conduct formal review and approval of authored documents per standard procedures
- Manage writing activities for new and supplemental drug/biologics applications
- Serve as functional lead on product teams and mentor junior medical writers
- Develop document timelines and participate in departmental initiatives
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.