Senior Manager – Global Regulatory Writing
Department: Global Regulatory Affairs / Regulatory Writing
Location: Hyderabad, India
Company: Amgen
Job ID: R-242349
Work Model: On-Site
Experience: 12–17+ Years
Education: PhD / PharmD / MD / MSc / M.Pharm / Life Sciences
Role Summary
The Senior Manager – Global Regulatory Writing is responsible for leading the preparation, review, approval, and delivery of complex scientific and regulatory documents supporting global clinical development and regulatory submissions.
The role serves as a strategic writing lead across product teams and therapeutic areas, ensuring high-quality, scientifically accurate, and regulatory-compliant documentation for worldwide health authority submissions. The incumbent will provide leadership to regulatory writers, manage cross-functional stakeholder relationships, and contribute to regulatory strategy execution.
Key Responsibilities
1. Regulatory Writing Leadership
Lead and oversee preparation of regulatory submission documents across all stages of drug development.
Ensure consistency, scientific accuracy, and compliance with global regulatory requirements.
Act as lead regulatory writer for major development programs and global submissions.
Develop document strategies aligned with regulatory objectives.
2. Authoring & Review of Regulatory Documents
Independently author, review, and approve:
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
Clinical Protocols
Protocol Amendments
Informed Consent Forms (ICFs)
Responses to Health Authority Questions
Briefing Documents
Pediatric Investigation Plans (PIPs)
Clinical Overviews and Addenda
eCTD Module 2 Clinical Summary Documents
Table of All Studies (TOAS)
NDA/BLA Supporting Documentation
Other global regulatory submission documents
3. Global Submission Support
Lead writing activities supporting:
IND Applications
NDA Submissions
BLA Submissions
Supplemental Applications
Global Regulatory Filings
Ensure alignment with:
FDA Requirements
EMA Requirements
PMDA Expectations
Global Regulatory Standards
4. Functional Area Leadership
Serve as Functional Area Lead on:
Global Regulatory Teams
Evidence Generation Teams
Global Safety Teams
Labeling Working Groups
Product Development Teams
Provide strategic input into Global Regulatory Plans.
Influence regulatory document strategy and timelines.
5. Cross-Functional Collaboration
Collaborate closely with:
Clinical Development
Medical Affairs
Pharmacovigilance
Biostatistics
Statistical Programming
Regulatory Affairs
Clinical Operations
Quality Assurance
Drive alignment between scientific, clinical, and regulatory stakeholders.
6. Team Leadership & Mentoring
Mentor and develop junior and mid-level regulatory writers.
Review and provide feedback on authored documents.
Manage freelance and contract writers.
Support capability building within the Regulatory Writing function.
7. Process Improvement & Governance
Lead departmental initiatives and process optimization projects.
Contribute to development and maintenance of:
SOPs
Writing Standards
Templates
Guidance Documents
Support inspection readiness and compliance initiatives.
8. Project & Timeline Management
Develop document plans and timelines.
Track deliverables and milestones.
Manage competing priorities across multiple projects.
Ensure timely delivery of high-quality regulatory documents.
Key Performance Indicators (KPIs)
Submission quality and acceptance rates
On-time document delivery
Regulatory inspection readiness
Document quality metrics
Cross-functional stakeholder satisfaction
Team development and mentoring outcomes
Process improvement contributions
Regulatory compliance performance
Required Qualifications
Education
Minimum
Doctorate Degree + 2 years relevant experience
OR
Master's Degree + 6 years relevant experience
OR
Bachelor's Degree + 8 years relevant experience
Preferred
MD
PharmD
PhD
M.Pharm
MSc Life Sciences
Required Experience
12–17+ years of experience in:
Regulatory Writing
Medical Writing
Clinical Development Documentation
Regulatory Affairs Support
Extensive experience supporting:
INDs
NDAs
BLAs
Global Regulatory Submissions
Experience leading regulatory writing teams and complex product submissions.
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