Global Regulatory Writing Manager – Amgen (On-site, Hyderabad, India)
Compensation / Salary: Not disclosed in the job description.
Experience Required: 9–13 years of directly related regulatory/medical writing experience.
Work Mode: On-site — Hyderabad, India
Category: Regulatory / Medical Writing
Job Summary (Pharma & Clinical Research Focused)
Amgen is seeking a Global Regulatory Writing Manager in Hyderabad, India to lead and author high‑impact regulatory submission documents that shape global approvals for innovative biologics and drugs. This senior medical/regulatory writing role spans Clinical Study Reports (CSRs), Investigator Brochures (IBs), eCTD Module 2 clinical summaries, Briefing Books, Protocols/Amendments, PIPs, and Responses to Health Authority Questions. You’ll collaborate cross‑functionally (Regulatory Affairs, Clinical Development, Safety, Evidence Generation, Labeling) and may serve as functional lead on product teams, manage submission writing strategy, mentor junior writers, and uphold compliance with ICH, GCP, and global regulatory standards.
Targeted at experienced regulatory writers in pharma/biotech with deep knowledge of ICH E3, ICH M4E(R2), GCP, CTD/eCTD, and end‑to‑end global submission strategy (NDA, BLA, sNDA/sBLA, MAA).
Key Responsibilities
Author, review, and manage high-quality regulatory documents: CSRs, IBs, Protocols & Amendments, ICFs, eCTD Module 2 Clinical Summaries, Briefing Documents, PIPs, Tables of All Studies, Clinical Overview Addenda, Responses to HA Queries.
Plan and oversee writing activities for global product submissions (with supervision), ensuring timelines, quality, and compliance.
Serve as functional writing lead on cross-functional global teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group).
Generate and manage document timelines, align deliverables across stakeholders, and ensure seamless handoffs to publishing/RA.
Mentor and train junior writers; oversee or collaborate with contract/freelance writers.
Ensure adherence to SOPs, ICH-GCP, internal style guides, templates, and regulatory guidance.
Stay current with evolving global regulatory guidance and best practices in regulatory medical writing.
Contribute to departmental initiatives, process improvements, standards, and knowledge management.
Required Skills & Qualifications
9–13 years of regulatory/medical writing experience in pharma/biotech/clinical research.
Advanced mastery of scientific/technical writing & editing for regulatory submissions.
Strong knowledge of ICH E3, ICH M4E(R2), ICH-GCP, CTD/eCTD structure & requirements.
Proven experience preparing NDA/BLA/MAA or equivalent global submission documentation.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) and document management tools.
Excellent written and verbal communication, leadership, project management, and cross‑functional collaboration skills.
Ability to interpret SOPs, guidance documents, HA requirements and apply them in writing strategy.
Comfortable leading timelines, negotiating inputs, and managing complex document workflows.
Nice-to-have / Preferred
Experience leading functional workstreams on global regulatory teams.
Experience working with/overseeing external vendors or freelance writers.
Exposure to labeling (SmPC, USPI), pediatric plans (PIP/PSP), safety documents, and evidence generation plans.
Familiarity with statistical outputs, data interpretation, and benefit-risk narratives.
Perks & Benefits (as stated / typically offered by Amgen)
Competitive & comprehensive Total Rewards Plan aligned with local market standards.
Career development & mentoring in a global, mission‑driven biopharma leader.
Collaborative culture with opportunities to influence global submissions and patient impact.
Robust learning ecosystem to stay current with regulatory science & medical writing best practices.
Company Snapshot (SEO-rich)
Amgen is a global, science‑first biopharmaceutical leader dedicated to transforming patient outcomes through innovative biologics, advanced clinical programs, and rigorous regulatory science. With a deep commitment to ethical standards, Amgen drives global submissions that bring life‑changing therapies to patients faster and more safely.
Work Mode
On-site, Hyderabad, India
Call to Action
Ready to lead pivotal global regulatory documents and influence submissions that reach millions of patients worldwide? Apply now and join Amgen’s mission to change the world through science.
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