Regulatory Affairs Specialist

• At least 3 years of experience.

• Ensures compliance with regulatory agency requirements and guidelines.
• Prepares responses to inquiries and other correspondence from regulatory authorities.
• Gathers and compiles information required for submissions in accordance with applicable regulations and guidelines; ensures that regulatory data is uploaded to the UTS database or submitted to other relevant authorities.
• Provides solutions to complex problems where data analysis involves the evaluation of non-tangible variables.
• Offers regulatory guidance to project teams.
• Organizes and maintains reporting schedules for drug, cosmetic, and medical device applications, as well as renewals.
• Executes processes required by the Ministry of Health.

Manpower