Regulatory Affairs Specialist

3 weeks ago

Makati City, Philippines Dempsey Resource Management Inc. Full time

Job Summary:
We are looking for a Regulatory Affairs Specialist to ensure that our products comply with all applicable regulations and requirements set by the Food and Drug Administration (FDA Philippines) and other relevant government agencies. The ideal candidate will be responsible for handling product registrations, renewals, license applications, compliance documentation, and regulatory submissions.

Key Responsibilities:
Prepare, compile, and submit product registration dossiers to the FDA (Philippines) and other regulatory bodies (e.g., DOH, BFAD, DENR, BOC)
Coordinate with internal departments (e.g., R&D, QA/QC, Marketing) for required documents and technical data
Monitor the status of product approvals, renewals, and license applications
Ensure compliance with all relevant local regulations for pharmaceuticals, food, cosmetics, or medical devices
Maintain and update regulatory files and databases
Provide regulatory advice during product development or marketing planning
Track changes in regulatory legislation and guidelines and communicate these updates to relevant teams
Handle product variations, labeling reviews, and post-market surveillance reports if required
Serve as the company’s point of contact with the FDA and other government agencies

Qualifications:
Bachelor’s Degree in Pharmacy, Chemistry, Biology, Food Technology, or any life science-related field
Preferably licensed Pharmacist (for pharmaceutical and drug-related companies)
At least 1–3 years of experience in regulatory affairs or product registration
Strong understanding of FDA Philippines regulatory processes and requirements
Excellent attention to detail and organizational skills
Strong communication and documentation skills
Proficient in MS Office (Word, Excel, PowerPoint)
Able to work independently and meet strict deadlines

Preferred but Not Required:
Experience in handling ASEAN Common Technical Dossier (ACTD/ACTR)
Familiarity with GMP, ISO, or HACCP standards (depending on industry)
Experience working with regulatory consultants or third-party laboratories.

Work Schedule:
Monday - Friday | 8am - 5pm

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