Regulatory affairs (onsite if needed - taguig city)
- Must have advance excel skills (Pivot and Vlookup)
To manage compliance documentation, preparing regulatory filings (applications, reports, renewals), and acting as a liaison between the company and regulatory agencies.
Job description:
- Regulatory support on all product registration projects and initiatives
o Obtaining manufacturing/distributing licenses and product certifications from the Food and Drug Administration (FDA) (Cosmetics + Household Urban Hazardous Substances)
o Assessments of product formulations for compliance to local regulations
o Maintenance of current FDA product registration inventory
o Delivery of product registrations and renewals as necessary
o Preparation of registration dossiers
o Maintenance of documentary filing and ensuring complete and easy access to Product Information Files as required by local regulations and by random/scheduled audits
o Documentation requirements preparation for random/scheduled audits
o Certificate of Free Sales requests
o Offline approval of regulatory text in local customization projects
o Share regulatory documents to multifunctions requesting them
o Build and Maintain PH Regulatory Requirements Database (reviewing and updating as new regulations come in) – FDA, DTI, DENR-EMB
o Build and Maintain PH Artwork Regulatory Requirements Checklists/Reference documents (reviewing and updating as new requirements come in)
o Consolidate FDA receipts and map and reconcile with support documents and cash advance requests prior to GPS filing into expense report- Regulatory support on all manufacturing related chemical registrations from the DENR – EMB
o Obtaining chemical registrations from the DENR – EMB
o Preparation of chemical registration dossier
o Maintenance of chemical registrations inventory
o Deliver renewals as necessary
Service Continuity Requirement:
o Agency to ensure proper transition period between contractors (especially licensed pharmacist)
Category Scope for Full Year
Work scope includes all GPS-scope categories which include the following: