Regulatory Affairs Specialist

Location

Delhi | India

Job description

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

• 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

Job tags

Salary