Address Overview:
The Regulatory Affairs Specialist is responsible for submitting relevant information to various regulatory agencies to obtain approvals for Cook products
Responsibilities: - 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
- Maintain professional appearance and conduct at all times
- Maintain confidentiality at all times
- Comply with Travel Policy and associated guidelines (if applicable)
- Domestic and International travel required (if applicable)
- Process expenses on Company Credit Card and submit expenses in a timely manner (If applicable)
- Degree in Science, Engineering or any other related disciplines
- 2-4 years of regulatory working experience in MNC, preferably in medical device or pharmaceutical industry
- Experience in negotiating with regulatory authorities would be an advantage
- Excellent organizational and interpersonal skills, positive working attitude and be a good team player.
- Attend to details and able to work with limit supervision.
- Able to work with both internal and external customers from different level
- Fluent in English both written and spoken.
- Able to prioritise tasks and complete on a timely manner with regular updates to the manager on the progress made
