Job Title:
Regulatory Affairs Manager – Chemistry, Manufacturing & Controls (CMC)
Job Information:
Job ID: R-224460
Location: India – Hyderabad
Work Type: On-site
Date Posted: August 29, 2025
Category: Regulatory
Company: Amgen
About the Role:
The Regulatory Affairs (RA) CMC Manager is responsible for the coordination and execution of global regulatory CMC activities for an assigned portfolio of commercial products. This includes providing strategic leadership, managing regulatory submissions, aligning global strategies, and ensuring regulatory compliance through collaboration with global and local CMC teams.
Key Responsibilities:
Regulatory Strategy & Planning:
Develop and execute global and country-specific regulatory strategies for CMC submissions.
Provide regulatory input and risk assessments to product teams.
Define minimum regulatory filing requirements, submission timelines, and strategies.
Identify and incorporate changes in external regulatory guidance into internal strategies.
Submission Execution & Support:
Lead the preparation of global CMC dossiers for:
Initial marketing applications
Variations and amendments
Support change management activities.
Develop and implement response strategies to health authority queries.
Cross-Functional Collaboration:
Liaise with:
Development, Operations, and Commercial functions to align on regulatory and supply strategies.
Local and regional regulatory teams to align on filing plans.
Coordinate with site and global CMC representatives to support regulatory deliverables.
Process & Data Management:
Ensure accurate and timely updates to Regulatory Information Management (RIM) and tracking systems.
Monitor department deliverables and maintain up-to-date submission records.
Follow established RA CMC processes to maintain cross-product alignment.
Contribute to process improvement initiatives within the RA CMC function.
Knowledge & Skills:
Strong understanding of regulatory CMC requirements.
Proven ability to develop and implement regulatory strategies.
Knowledge of global submission requirements and regulatory processes.
Experience collaborating across cross-functional and international teams.
Education & Experience Requirements:
Minimum Qualifications (any one of the following):
Doctorate degree
Master’s degree with 3 years of directly related experience
Bachelor’s degree with 5 years of directly related experience
Required Experience:
Experience in manufacturing, testing (QA/QC or clinical), or distribution
Hands-on Regulatory CMC experience
Why Amgen?
Be part of a global biopharma leader impacting millions of lives.
Work in a collaborative, science-driven environment.
Grow your career through global exposure, innovation, and continuous learning.
Apply Now:
Click Here to Apply
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