Manager Regulatory Affairs - Delhi

About the role

Registration of NCE and line extensions for therapeutic area of responsibility Strategies compliant with regulations, Liaise with Health Authority and ensure earliest submission and registration in the country. Renewal on time to ensure uninterrupted availability of products in the country. Amendments and updates are approved on time to ensure study is continued in the country and ensure timely notification of notifiable updates.

What you'll do

• Follow-up regulatory approvals for the products per registration plan
• Liaise with Health Authority regularly and engage in impactful discussion with Senior Regulatory officials
• Ensure earliest submission & approvals at the right time to ensure quick implementation of proposed CMC changes as per global timelines
• Follow-up on submitted applications at HA

What you need

• 8–10 yrs of experience
• Regulatory affairs
• Communication
• Any graduate