Job Title: Regulatory Affairs CMC Manager (SPPM)
Location: India – Hyderabad (On Site)
Job ID: R-208538
Date Posted: April 16, 2025
Category: Regulatory
Company: Amgen
Job Summary
Amgen is looking for a Regulatory Affairs CMC Manager to join the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs. This position will focus on developing, maintaining, and driving consistency across CMC processes, ensuring continuous improvement, and shaping the training strategy across the organization. The role will require strong collaboration, project management, and process documentation skills to support regulatory practices at a global level.
Key Responsibilities
Develop, maintain, and improve CMC processes and procedures
Support new hire onboarding and training programs
Facilitate communication across Global CMC & Device Regulatory Affairs
Drive consistency in practices and procedures across the team
Continuously improve templates for presentations, timelines, trackers, and tools
Liaise with internal functions and external stakeholders for alignment
Participate in cross-functional special project teams
Potentially oversee or manage staff within the team
Required Skills and Experience
Doctorate with 7-8 years, or Master's/Doctorate with 8-12 years, or Bachelor’s degree with 10-13 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Experience with Regulatory Affairs, CMC, Manufacturing, or Quality Assurance/Control
Working knowledge of Regulatory CMC processes and global submission requirements
Experience in developing or managing SOPs, process documentation, or training programs
Familiarity with regulatory systems like Veeva Vault RIM or electronic document management
Certification in project management or process improvement methodologies (e.g., Lean, Six Sigma) is a plus
Preferred Skills
Strong project management and organizational skills
Excellent communication skills (written and verbal)
Ability to collaborate across global, cross-functional teams
Experience in onboarding, training, and continuous improvement initiatives
Comfort working in a fast-paced, deadline-driven environment
Why Join Amgen
Work with a collaborative and innovative culture
Make a lasting impact in the biotechnology field
Competitive benefits and Total Rewards Plans
Opportunities for professional and personal growth
How to Apply
Visit: careers.amgen.com
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