Regulatory Pharmacist
5 days ago
Job Description
- Prepare and check submissions of License to Operate, Cosmetic Notifications, CPRs, and other related regulatory correspondence with FDA.
- Check product labels conforming to ACD Standards.
- Ensure that all FDA license, certificates, and permits are updated and valid.
- Coordinate with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
- Develop and maintain a schedule of periodic updates for all regulatory submissions.
- Ensure updates are filed within timelines.
- Compile and maintain complete technical data of each product.
- Conduct Suppliers and Toll Manufacturing audits as needed.
- Update related departments on latest regulatory requirements.
- Conduct product tests for all finished goods distributed and imported by the company.
- Coordinate and monitor the destruction and disposal of rejected, damaged, or expired finished product and components.
- Perform other related duties as required by FDA and other tasks assigned as needed.
Minimum Qualifications
- Must be a Registered Pharmacist.
- At least one (1) year work related experience in the regulatory field.
- Computer literate.
- Good communication skills.
- Can work independently.
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