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
