Regulatory Affairs Manager

Job Purpose

• Locally manage the overall Regulatory Affairs and Pharmacovigilance functions. Liaise and negotiate with FDA on Regulatory issues.
• Ensure that the Quality Management System (QMS) is effectively executed, monitored and adhered to within the department and company.
• Manages the regulatory, quality and compliance aspects of partnering activities, ensuring smooth transitions and compliance for in-licensed and out-licensed products.

Major Accountabilities

REGULATORY

• Provides regulatory expertise to the business
• Serves as the chief negotiator with government agencies during the review and approval process
• Leads and manages the entire registration process and other FDA related activities. Strategically plans regulatory action to ascertain product approval
• Accountable f...