Manager - International Regulatory Lead
HyderabadFull-timeSenior levelPosted over a month ago
Senior legal role at Amgen in Hyderabad.
About the role
The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to
What you'll do
- Optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country…
- Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals
- Develop the international regulatory strategy and contribute to Global regulatory plans
- Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments)
- Support and advise on the local label strategy and alignment to cCDS/reference label
What you need
- Compliance