Amgen Hiring Sr Associate Regulatory Affairs | Apply Now!

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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