We are seeking for a detail-oriented and proactive Regulatory Specialist to join our team. In this role, you will be responsible for ensuring that all pharmaceutical products comply with local regulatory requirements and company standards. You will work closely with cross-functional teams, external partners, and regulatory agenciesIPO, DOH, Local Laboratories and FDA.
Key Responsibilities
- Assist the Regulatory Department by ensuring the availability of all the company and product documents on file for FDA inspection and requests, as needed.
- Assist in maintaining the trademark (TM) registrations, ensuring that TMs are maintained in the IPO system.
- Maintain EDPS Certificate and ensures timely quality submission of reports to the DOH.
- Submission of monthly reports as required.
- Safekeeping of retention samples, COAs, logbooks required by the FDA, and facilitating the local assay for all the commercial products.
Qualifications
- Bachelor's degree in Pharmacy
- Licensed Pharmacist preferred (but not required depending on experience).
- Minimum 5 year of experience as a company pharmacist within a pharmaceutical industry handling drug products.
- Preferably with knowledge on FDA inspection, basic company and product documents, and trademarks.
- Advantage if with experience in FDA submissions and Quality Assurance
- Excellent documentation, writing/drafting letters and various reports.
