GLOBAL REGULATORY WRITING – SENIOR MANAGER
Company: Amgen
Location: Hyderabad, India
Work Mode: On-Site
Job ID: R-242349
Category: Regulatory
JOB OVERVIEW
The Global Regulatory Writing Senior Manager is responsible for authoring, reviewing, and leading the preparation of scientific and regulatory submission documents that comply with global regulatory standards. The role acts as a functional lead on cross-functional product teams, manages complex regulatory writing projects, mentors junior writers, and contributes to departmental initiatives.
KEY RESPONSIBILITIES
• Regulatory Document Authoring
Author or oversee preparation of regulatory submission documents.
Ensure documents comply with global regulatory requirements.
Lead document review and approval processes.
• Documents Covered
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
Clinical Protocols
Protocol Amendments
Informed Consent Forms (ICFs)
Responses to Regulatory Authority Questions
Table of All Studies (TOAS)
Clinical Overview Addenda
eCTD Module 2 Clinical Summary Documents
Briefing Documents
Pediatric Investigation Plans (PIPs)
NDA and BLA submission documents
Other regulatory submission documents
• Submission Leadership
Lead regulatory writing activities for complex submissions.
Support New Drug Applications (NDAs).
Support Biologics License Applications (BLAs).
Manage supplemental submissions.
Develop submission strategies and timelines.
• Cross-Functional Leadership
Serve as Functional Area Lead on:
Global Regulatory Teams
Evidence Generation Teams
Global Safety Teams
Label Working Groups
Contribute to Global Regulatory Plans.
Support strategic product development goals.
• Team Management
Mentor and train junior medical writers.
Supervise freelance and contract writers.
Review writing deliverables and provide guidance.
Lead departmental and cross-functional initiatives.
• Scientific Data Interpretation
Analyze and interpret scientific and clinical data.
Translate data into regulatory narratives.
Ensure scientific accuracy and consistency across submissions.
• Project Management
Generate and manage document timelines.
Coordinate with stakeholders across functions.
Track milestones and deliverables.
Ensure timely submission readiness.
REQUIRED KNOWLEDGE & SKILLS
Scientific Writing
Regulatory Writing
Medical Writing
Clinical Development Knowledge
Regulatory Submission Expertise
Scientific Data Interpretation
Leadership & Mentoring
Stakeholder Management
Project Management
SOP Development & Compliance
Microsoft Office Expertise
PREFERRED KNOWLEDGE
ICH Guidelines
Good Clinical Practice (GCP)
eCTD Submission Requirements
Advanced Document Management Systems
Global Regulatory Strategy
EDUCATION
One of the following:
Doctorate Degree + 2 Years Relevant Experience
Master's Degree + 6 Years Relevant Experience
Bachelor's Degree + 8 Years Relevant Experience
Associate Degree + 10 Years Relevant Experience
High School Diploma + 12 Years Relevant Experience
PREFERRED EXPERIENCE
Pharmaceutical Industry Experience
Regulatory Submission Experience
IND to NDA/BLA Documentation Experience
EXPERIENCE
12–17 Years
Clinical Regulatory Writing
Medical Writing
Global Submission Documentation
NDA/BLA Submission Support
Regulatory Affairs Collaboration
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Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Donegal |Meath :
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China | Quarry Bay |Liaoning :
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Queensland |Melbourne :
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Canada |Quebec :
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