Regulatory Affairs Specialist

Overview

The Regulatory Affairs Specialist is responsible for submitting relevant information to various regulatory agencies to obtain approvals for Cook products

Responsibilities

 Essential Job Functions

• Coordinate and Manage timely Regulatory Submissions between local company and our own overseas Manufacturers.
• Coordinate and implement the registration process for the company products
• Act as a bridge between the legal bodies and the company.
• Work with our manufacturers to provide strategy and multiple options for meeting regulatory requirements
• Personally write and review regulatory submissions as needed
• Organize electronic database (electronic library) of Regulatory Documents and government notifications on GTW (Global Technical Warehouse)
• Create training documents to improve regulatory skills in Local office and other manufacturers
• Train employees to improve regulatory skills in local office or region and at our manufacturers, where applicable
• Negotiate with local authorities on behalf of Company objectives
• Support reimbursement efforts for submissions when applicable
• Represent the company as a member of industry organizations

Qualifications

• Degree in either science, engineering, pharmacy or related discipline is desirable
• 2 years of regulatory working experience in MNC, preferably in medical device or pharmaceutical industry
• Experience in negotiating with regulatory authorities would be an advantage
• Intermediate Microsoft Office proficiency (Excel, Word, PowerPoint) essential