Job Title:
Regulatory Affairs Senior Manager (CMC)
Job Details:
Job ID: R-223044
Location: India – Hyderabad
Work Type: On-site
Date Posted: August 29, 2025
Category: Regulatory
Company: Amgen
About the Role:
The RA CMC Senior Manager is responsible for the execution and coordination of global regulatory CMC activities. This includes providing leadership, guidance, and strategic oversight for the regulatory strategy of assigned commercial products. The role involves communicating regulatory strategy, risks, and issues to senior management and collaborating with site and regional CMC representatives to ensure successful global regulatory activities.
Key Activities:
Serve as Global RA-CMC lead or supervisor for one or more products within product teams
Provide strategic regulatory input and risk assessments for product teams
Execute regulatory strategy related to preparation of submissions and ensure compliance with critical RA CMC processes
Identify and recommend process and strategy changes aligned with Amgen initiatives and external regulatory policies
Incorporate changes in regulatory guidance into CMC strategies and provide updated guidance to product teams
Report issues to RA CMC product team management
Key Responsibilities:
Oversee CMC strategy deliverables and submissions for a portfolio of products at various development stages
Engage with external stakeholders such as regulatory agencies and professional bodies to influence regulatory policy globally
Identify and communicate regulatory risks, ensuring aligned mitigation plans across products
Provide coaching, mentoring, and support for junior CMC Regulatory Affairs staff development
Define minimal regulatory filing requirements, submission strategies, and conduct regulatory risk assessments for assigned projects
Develop and execute response strategies for health authority questions
Collaborate with development, operations, and commercial teams to align regulatory strategies, timing, execution, and supply plans
Coordinate with local regulatory teams to align filing strategies
Monitor and update tracking systems and maintain submission data in the Regulatory Information Management (RIM) system
Follow established regulatory processes to ensure alignment across products
Knowledge and Skills:
Deep regulatory CMC-specific knowledge and experience
Experience in staff management and development
Education & Experience (Basic):
Doctorate degree
OR
Master’s degree with 3 years of directly related experience
OR
Bachelor’s degree with 5 years of directly related experience
OR
Associate’s degree with 10 years of directly related experience
Additional Experience:
Experience in manufacturing, testing (QC/QA or clinical), or distribution
Regulatory CMC experience
What You Can Expect from Amgen:
Support for professional and personal growth and well-being
Competitive benefits and collaborative culture
Comprehensive Total Rewards Plans aligned with local industry standards
Inclusive work environment fostering diversity, ethics, and commitment to science and patients
Equal Opportunity Statement:
Amgen is an Equal Opportunity employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other protected basis under applicable law.
Reasonable accommodations are provided for individuals with disabilities during the hiring process and employment. Please contact Amgen to request accommodations.
Apply Now
For a career that defies imagination: careers.amgen.com
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