Job Title: RA CMC Senior Manager
Location: Hyderabad, India (On-site)
Job ID: R-224177
Category: Regulatory
Posted Date: August 29, 2025
About Amgen
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and make people’s lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients worldwide.
Role Summary
The RA CMC Senior Manager is responsible for the execution and coordination of global regulatory CMC (Chemistry, Manufacturing, and Controls) activities. This role provides leadership, guidance, and insight to ensure the successful execution and implementation of regulatory strategies for an assigned portfolio of commercial products. The manager communicates regulatory strategies, risks, and issues to Regulatory and Operations senior management and collaborates with internal and external stakeholders to execute global regulatory activities.
Key Responsibilities
Serve as Global RA-CMC lead or supervisor for one or more products and contribute to cross-functional product teams.
Provide strategic regulatory input and risk assessments to product teams.
Develop and execute regulatory strategies, including preparation of submissions.
Ensure compliance with critical RA CMC processes and identify opportunities for process and strategy improvements.
Incorporate changes in external regulatory guidance into CMC strategies and guidance for product teams.
Communicate regulatory risks and mitigation plans to management and stakeholders.
Coach, mentor, and support the professional development of junior CMC Regulatory Affairs staff.
Develop CMC regulatory strategies for assigned projects by defining minimal filing requirements, submission plans, and risk assessments.
Liaise with internal functions (development, operations, commercial) to ensure alignment on global regulatory strategies, timing, execution, and supply plans.
Collaborate with local regulatory teams to align on filing strategies.
Monitor, track, and maintain submission information in Regulatory Information Management (RIM) systems.
Follow established regulatory processes to ensure cross-product alignment.
Key Activities
Oversee deliverables for CMC strategy and submissions across the assigned product portfolio.
Engage with regulatory agencies and professional bodies to influence regulatory policy.
Identify and communicate regulatory risks across products and ensure aligned mitigation strategies.
Contribute to process improvements and report changes needed to meet internal and external regulatory requirements.
Required Knowledge & Skills
Regulatory CMC-specific knowledge and experience.
Staff management and team development experience.
Strong strategic thinking and cross-functional collaboration skills.
Education & Experience
Doctorate degree in a relevant field
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
Experience in manufacturing, testing (QC/QA or clinical), or distribution.
Proven regulatory CMC experience.
What We Offer
A collaborative, inclusive culture that supports personal and professional growth.
Competitive base salary with comprehensive Total Rewards aligned with local industry standards.
Opportunity to work on treatments that improve patient lives globally.
Equal Opportunity Employer Statement
Amgen is an Equal Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected category under applicable law.
Reasonable accommodations are provided to individuals with disabilities to participate in the application or interview process, perform essential job functions, and receive other benefits of employment.
Apply Now
Take the next step in a career that defies imagination. Join Amgen and contribute to advancing science to serve patients worldwide.
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