Executive, Regulatory Affairs NPD US & Can

About the role

Preparation of new submissions and deficiency responses to Regulatory agencies (US and Canada) for Injectables (Sterile Dosage Forms) Review of quality documents required for regulatory NPD submissions and deficiency responses. Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures.

What you'll do

• Responsible for the preparation and review of quality regulatory NPD submissions for various markets (US and Canada) to ensure timely approval for Injectables (Sterile…
• Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets (US and Canada)
• Responsible for review of quality/regulatory documents for new submissions and deficiency responses
• Accountable for assessment, coordination and compilation of deficiency responses in a timely manner
• Works with other functional areas to resolve issues related to information for regulatory submissions

What you need

• 4–7 yrs of experience
• Regulatory affairs
• MS Project
• Chemistry
• Biology
• Communication
• SOP writing
• Any graduate