Specialist, Regulatory Affairs
Core
Specialist responsible for all aspects of regulatory submissions in the Philippines, managing post-marketing Lifecycle Management (LCM) activities, and ensuring products meet local legislations and company procedures.
Role type
Specialist Regulatory Affairs (Pharmaceuticals/Medical Devices)
Builds
Regulatory compliance and supply continuity for new/established products in the Philippines
Domain
Healthcare / Pharmaceuticals / Medical Devices
Required skills
Regulatory submission preparation, Lifecycle Management (LCM), local regulation expertise, audit support, SOP compliance, cross-functional collaboration
Preferred skills
CMC knowledge, drug shortage management, process improvement
Technologies
Regulatory databases, submission systems
Responsibilities
Drive product registration plans and strategies; Prepare and submit Marketing Authorization Applications and post-market dossiers; Maintain regulatory data and documentation; Ensure compliance with global and local SOPs; Support local audits and inspections; Develop local procedures and evaluate process improvements.
Seniority
Specialist, hands-on IC