Regulatory Affairs Manager (Site)
Amgen
About this role
The Regulatory Affairs Manager within RA CMC supports product development and global registration by developing and executing regulatory strategies for product manufacturing and quality across the product lifecycle. This role is part of the Regulatory Compliance team based in India and focuses on maintaining U.S. state and federal commercial product licenses and assessing operational changes for regulatory reportability. The position collaborates with Global CMC, Site CMC, Device Regulatory, Operations, Quality, and Supply Chain teams to support licensed products.
Skills
Qualifications
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
Recent company news
Amgen Named to Forbes’ 2026 List of America’s Best Large Employers
2 days ago
Franklin Resources Inc. Lowers Position in Amgen Inc. $AMGN
4 hours ago
Amgen Touts 2025 Double-Digit Growth, MariTide Obesity Push and BiTE Momentum at Leerink Conference
13 hours ago
Gilead Gets a Buy, Amgen a Hold and ORIC a Vote of Confidence: Wall Street's Latest Biopharma Calls Explained
1 day ago
Q4 Earnings Highs And Lows: Amgen (NASDAQ:AMGN) Vs The Rest Of The Therapeutics Stocks
3 days ago
About Amgen
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
Unlock Company Insights
View leadership team, funding history,
and employee contacts for Amgen.
Salary
$0
per year
More jobs at Amgen
Similar Jobs
Senior Regulatory Affairs Specialist
Cepheid
Head of Global Regulatory Affairs, CMC Small Molecule
Sanofi
Regulatory Affairs Specialist 3
Intuitive
Associate Director, Regulatory Affairs, CMC
GE HealthCare
Global Regulatory Affairs Device Lead (Associate Director)
Sanofi
Senior Manager, Regulatory Affairs CMC
MSD