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
