Specialist, Regulatory Affairs

About This Role

This specialist role is responsible for all aspects of regulatory submissions in the Philippines, combining scientific and regulatory knowledge to ensure new and established products meet local legislation and company procedures. The role manages post-marketing lifecycle management activities and external regulatory surveillance, collaborating with cross-functional teams to enhance regulatory initiatives and ensure supply continuity. This position reports to the Country/Cluster Regulatory lead and may act as the regulatory license holder.

Responsibilities

• Drive product registration plans and strategies and work cross-functionally to communicate and execute the registration strategy
• Timely preparation and submission of new Marketing Authorization Applications to local Health Authorities
• Maintain authorized products through timely submission of post-market regulatory dossiers, including variations, renewal applications, and supplemental marketing authorization in accordance with local regulations and global standards
• Archive and maintain regulatory data and documentation in accordance with department and company policies and local requirements, including product licenses, import, and distribution of pharmaceuticals and medical devices
• Ensure compliance with global and local SOPs and report any deviations or compliance concerns immediately
• Assist in preparing necessary corrective actions and preventive actions (CAPAs) locally for non-compliance issues
• Support local audits, inspections, and readiness activities, including audits of contractual partners/vendors and response to findings/observations
• Assist in developing local procedures (in compliance with regional and global standards) for the department and evaluate processes for potential improvement in efficiency and effectiveness
• Proactively identify procedural gaps and challenges and implement solutions in collaboration with all affected stakeholders
• May be assigned to support drug shortage management and regulatory requirements for reporting, including collaborating with local Quality and Supply Chain to avoid supply constraints
• Ensure awareness of obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain

Requirements

• Minimum of 3 to 5 years of industry experience in regulatory affairs and/or CMC in a multinational corporation or local market
• Local registered pharmacist is required
• Sound knowledge of regulations within the assigned markets and expertise in local regulatory processes and activities
• University Degree, B.Sc. or higher in Health Sciences (including chemistry, biochemistry, physiology) or equivalent