Looking for better
be part of our team
Job Openings in Kittelson & Carpo Consulting
We are a fast-growing consulting firm in the Philippines with many job options for talented individuals with tax, accounting, legal, HR and corporate services experience.
FDA Regulatory Affairs Officer
Department/Company: Legal Compliance Department (LCD)
Number of Vacant Position/s: 1
- 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
- Works with FDA/BFAD/DOH on product registration and other regulatory requirement needed to support the clients
- 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)
- Coordinate, compile, organize, and review client’s documents for pre-submission to FDA
- Monitor and maintain necessary record-keeping on new regulations, regulatory information and other regulatory issues;
- Interpret regulatory rules or rule changes and ensure that they are communicated with the potential clients, existing clients, and legal compliance manager.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- Compile and maintain regulatory documentation databases or systems and fill-out the FDA client and inquiry tracker shared with the LCD manager
- Preparation and submission of document to FDA/BFAD/DOH such as LTO and CPR
- Support and promote good relation with regulatory institutions and its practices and other related organization
- Ensure that all FDA licenses, and permits are updated and valid.
- Maintain and update all files related to product registration and other regulatory requirements.
- Properly file, monitor and closely follow-up statuses of applications in the above-mentioned regulatory bodies
Submit your resume to [email protected]
Please include the position you are applying for in the subject of the email.