Amgen Hiring Sr Associate Regulatory Affairs | Apply Now!
Job Details
- Company: Amgen
- Position: Sr. Associate – Regulatory Affairs
- Location: Hyderabad
- Experience: 0 – 6 years
- Qualification: B.Pharm, M.Pharm, M.Sc, B.Sc (Life Sciences)
- Application Deadline: February 3, 2025
- Work Mode: Full-time, Work from Office
Key Responsibilities
- Lead submissions for annual reports, facility registrations, renewals, and product updates.
- Collaborate with authors and subject matter experts for CMC document delivery.
- Prepare submission content plans for regulatory CMC submissions.
- Coordinate and legalize country-specific CMC documents.
- Manage and archive CMC submissions in document management systems.
- Maintain CMC product timelines in alignment with project goals.
- Interface with the regulatory operations team for smooth workflow.
- Train staff on CMC procedures and systems.
- Participate in cross-functional special projects.
Qualifications & Eligibility Amgen Hiring Sr Associate Regulatory Affairs
Required Qualifications:
- Master’s Degree OR
- Bachelor’s Degree with 1-2 years of experience in manufacturing, QA/QC, or regulatory CMC in pharmaceuticals/biotechnology OR
- Associate’s Degree with 6 years of relevant experience OR
- High School Diploma/GED with 8 years of relevant experience.
Preferred Qualifications & Skills:
- Bachelor’s Degree in Life Sciences preferred.
- Experience in manufacturing, process development, QA, or analytical development.
- Strong knowledge of regulatory CMC processes.
- Project management and organizational abilities.
- Excellent oral and written communication skills.
- Familiarity with Veeva Vault platforms for document management.
Why Join Amgen?
- Work-life balance with structured work schedules.
- Work on challenging projects in biotechnology.
- Competitive salary with insurance benefits.
- Global career growth opportunities in regulatory affairs.
How to Apply?
📩 Apply Online
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