Job Description

🌍 We’re hHiring: Senior Manager, Global Regulatory Writing | Amgen India | Hyderabad

At Amgen, we pioneer biotech to transform lives. With six therapeutic areas spanning oncology, inflammation, obesity, generalmedicine, biosimilars, and raredisease, our mission is to serve patients living with serious illnesses.

📍 Location: Hyderabad, India (Onsite role)

In this role, you will:
✍️ Lead and oversee regulatory submission documents (CSR, CTD sections, Investigator Brochures, briefing docs)
🤝 Collaborate with cross-functional teams to drive submission strategy
🌟 Manage and mentor medical writers to ensure quality and compliance

What we’re looking for:
✔️ 13–18 years of regulatory/ clinical writing experience
✔️ Mandate skills: Expertise in CTD sections, clinical study reports, Investigator Brochures, and global submission standards (ICH guidelines)
✔️ Strong leadership, project management, and collaboration abilities

If you’re ready to lead impactful submissions that bring innovative therapies to millions of patients, join us at Amgen. 👇

🔗 Apply today: https://amgen.wd1.myworkdayjobs.com/Careers/job/India—Hyderabad/Senior-Manager–Global-Regulatory-Writing_R-222090