Regulatory Affairs Associate

• Assist in preparing all the technical documents required for submission to FDA and other regulatory agencies
• Responsible for ensuring that all product registrations, licenses, and certificates are valid and submitted to the FDA for renewal prior to the expiration date
• Update and monitor the registration status and validity date of all regulatory certificates and licenses
• Establish and maintain document filing system to ensure easy access
• Participate in inspections of company facilities by FDA and other applicable agencies
• Submission of Quarterly report for DOH EDPMS
• Act as a Person in charge, liaison to local regulatory bodies
• Assist in the preparation of Bidding Documents for submission on Public Bidding for Hospitals
• Assist in preparing Requirements for Hospital needs.
• Assist in Sales concerns about product specification and other concerns.
• Assist the Marketing Department with Promo Permits for FDA compliance
• Handles Batch Notification for FDA Monitoring
• Provides support and assistance to Regulatory Affairs Head
• Perform other regulatory-assigned activities and roles in support of business objectives

• Must be a Licensed Pharmacist
• With experience working in Regulatory
• Fresh graduates are welcome to apply
• Background in handling government account procedures is an advantage
• Excellent leadership and management skills
• Honest, patient, and hardworking
• Willing to work onsite from Monday to Friday

Work Location: In person