Regulatory & Compliance Associate

DUTIES AND RESPONSIBILITIES:

• Representing the company in complying with the requirements of the government regulating bodies on products and facilities, except for local permits.
• Check the necessary documents, including the Product Information File (PIF), as required for FDA product registration.
• Must understand all aspects of product development, including research, clinical trials/tests, manufacturing practice, regulations, and approval process.
• Participating with project teams on the regulatory requirements for export, labelling requirements, or clinical study compliance.
• Provide and explain regulations to determine the impact on company activities.
• Identify and interpret regulatory guidelines

QUALIFICATION AND EDUCATION REQUIREMENTS:

• Licensed Pharmacist, Chemical Engineer, or Chemical Technician
• Relevant years of related work experience
• Proficient in oral & written communication
• Computer Literate