Manager, Regulatory Affairs

About the role

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects.

What you'll do

• Represent Regulatory Affairs on assigned product and related project team (both internal and external cross-functional teams)
• Provide regulatory assessment of due diligence requests to support new business development activities
• Serve as primary interface with FDA and other health authorities and regulatory agencies for assigned products
• Drive regulatory strategies for drug product registration and life-cycle management across global markets
• Manage regulatory filings including IND, NDA, ANDA and NDS for a variety of dosage forms including solid oral, parenteral, liquids, inhalation and nasal

What you need

• 8–10 yrs of experience
• Regulatory affairs
• GMP
• Due diligence
• SOP writing
• ETL
• Communication
• B.Sc or M.Sc or M.Pharm or PhD