Job Openings in Kittelson & Carpo Consulting

Department/Company: Legal Compliance Department (LCD)
Number of Vacant Position/s: 1

Requirements:

• Must be a licensed pharmacist
• Must be knowledgeable in PH FDA/BFAD/DOH procedures, regulations and processes; at least 1 year relevant experience
• Must have excellent communication and interpersonal skills
• Must be confident, detail oriented, adaptable and must have the ability to work independently.
• Must be computer literate
• Must be willing to work in BGC

Job Description:

1. Works with FDA/BFAD/DOH on product registration and other regulatory requirement needed to support the clients
2. Ensures that LTOs, CPRs of drug/cosmetic products are up to date and in compliance with the regulatory requirements of the Food and Drug Administration (FDA)
3. Coordinate, compile, organize, and review client’s documents for pre-submission to FDA
4. Monitor and maintain necessary record-keeping on new regulations, regulatory information and other regulatory issues;
5. Interpret regulatory rules or rule changes and ensure that they are communicated with the potential clients, existing clients, and legal compliance manager.
6. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
7. Compile and maintain regulatory documentation databases or systems and fill-out the FDA client and inquiry tracker shared with the LCD manager
8. Preparation and submission of document to FDA/BFAD/DOH such as LTO and CPR
9. Support and promote good relation with regulatory institutions and its practices and other related organization
10. Ensure that all FDA licenses, and permits are updated and valid.
11. Maintain and update all files related to product registration and other regulatory requirements.
12. Properly file, monitor and closely follow-up statuses of applications in the above-mentioned regulatory bodies