🌟 Exciting Career Opportunity at Amgen – Regulatory Affairs, CMC 🌟
Amgen, a global leader in biotechnology, has been transforming medicine through scientific innovation for over 40 years. As a Fortune 500 company, Amgen is committed to improving lives by developing groundbreaking therapies for serious illnesses. 💊✨
📌 About the Role – RA CMC (Regulatory Affairs, Chemistry, Manufacturing & Controls)
The RA CMC team plays a crucial role in product development and global regulatory submissions, ensuring compliance throughout the product lifecycle. Amgen’s Regulatory Optimization of Tactical and Strategic Support (ROOTS2) team is expanding in India to strengthen CMC submission execution across different development phases and global markets. 🌍
🔍 Key Responsibilities
As a ROOTS2 team member, you will collaborate with global regulatory teams and contribute to the execution of CMC regulatory strategies. Your role will involve:
✅ Leading submissions for annual reports, facility registrations, renewals, and product updates.
✅ Coordinating with authors, reviewers, and subject matter experts for regulatory submission documents.
✅ Preparing content plans for CMC submissions, including IND/CTA filings, marketing applications, and post-market updates.
✅ Managing country-specific regulatory documentation, collection, and legalization.
✅ Archiving submissions and tracking regulatory communications in the document management system.
✅ Supporting project timelines and collaborating with regulatory operations teams.
✅ Providing training on CMC procedures and systems.
✅ Participating in cross-functional projects and reporting activity status to teams.
🎓 Qualifications You’ll Need
Basic Requirements:
📌 Master’s degree OR
📌 Bachelor’s degree + 1-2 years of experience in manufacturing, QA/QC, or regulatory CMC in the pharmaceutical/biotech industry OR
📌 Associate’s degree + 6 years of experience OR
📌 High school diploma/GED + 8 years of relevant industry experience.
Preferred Qualifications:
✔️ Bachelor’s degree in Life Sciences.
✔️ Experience in manufacturing, process development, quality assurance, or analytical development.
✔️ Strong knowledge of regulatory CMC.
✔️ Excellent project management & communication skills.
✔️ Familiarity with Veeva Vault platforms.
🚀 Ready to take the next step in your career? Apply now! 👉 Click Here