Specialist- Commercial Regulatory Affairs

About the role

The Specialist, Commercial Regulatory Affairs is responsible for preparation, submission and approvals for the Import license applications, renewals, and Post Approval change applications and ensure filings are following Country specific regulations and guidelines, with a focus on India, Sri Lanka and other SWA countries

What you'll do

• Working together, let’s put our time and talents together to advance human health for tomorrow
• Responsible for preparation, submission and approvals for the Import license applications, renewals
• Responsible for the coordination with Business Units Regulatory Affairs team in requesting documents for the applications
• Responsible for timely responding to the queries raised by the Regulatory authority regarding the application submitted. Responsible for ensuring in meeting the project…
• Collaborate with cross-functional departments to complete the process for the products that require in-country testing data for registration purposes

What you need

• Regulatory affairs