Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for supporting regulatory activities related to the registration, maintenance, and compliance of pharmaceutical products as well as Quality Assurance and Pharmacovigilance activities to ensure adherence to FDA requirements, applicable regulations, and company procedures.

Key Responsibilities:

Regulatory Affairs

Product Registration and Licensing

Responsible for reviewing regulatory dossiers and preparing and submitting product registration applications, including the development and review of product artworks and labelling materials, as well as the submission, renewal, and maintenance of Foreign GMP Clearances.

and review of product artworks and labelling materials.

Product Lifecycle Management

Responsible for supporting products throughout their lifecycle by maintaining regulatory dossiers, monitoring CPR validity and submitting renewal applications, tracking regulatory commitments and approval conditions, preparing and implementing variations and post- approval changes, ensuring product information remains aligned with FDA-approved documents, and reviewing product labels, packaging materials, package inserts, and promotional materials for regulatory compliance..

Various Reports/Documentation

Responsible for preparing, submitting, and monitoring regulatory reports and documentation required by the FDA and other government agencies, including destruction reports, test analyses, certifications, clearances, and other compliance-related documents; ensuring the availability and proper maintenance of FDA documents; and coordinating the timely procurement and follow-up of supporting documents required for regulatory, bidding, collection, and other business purposes.

Regulatory Agency Liaison

Serves as the point of contact with the FDA and other relevant government agencies on regulatory matters; coordinates responses to regulatory queries, deficiency letters, and requests for additional information; assists in regulatory inspections and audits; and collaborates with internal departments and external partners to ensure timely and complete compliance with regulatory requirements.

Regulatory Intelligence

Monitors and evaluates updates to Philippine FDA regulations, administrative orders, circulars, guidelines, and other applicable regulatory requirements; communicates relevant regulatory changes to concerned departments; and supports the development and implementation of regulatory procedures and compliance activities.

Quality Assurance

Responsible for overseeing and executing Quality Assurance activities, participating in external and internal QA audits; managing product complaints, temperature excursions, and periodic reconciliation with manufacturers and distributors; managing QA-related contracts and training; conducting and approving transport validation; handling and approving deviations, recalls, and other QA issues; and overseeing secondary packaging sites and processes

Pharmacovigilance

Responsible for overseeing and executing pharmacovigilance activities, ensuring compliance with local PV regulations; supporting health authority, partner, and other PV audits and resolving related CAPAs; conducting reconciliation with product owners, affiliates, distributors, and service providers; reviewing PV provisions in agreements and contracts; assessing PV service providers; conducting PV training; overseeing the performance of outsourced PV activities including literature monitoring, case processing, and signal detection; and reviewing and disseminating PV-related reports.

Cross-Functional Coordination and Records Management

Coordinates with Regional and local Quality Assurance, Supply Chain, Medical, Commercial, and other relevant departments, as well as manufacturers, distributors, and business partners, to ensure timely fulfilment of regulatory requirements and provision of supporting documents; maintains complete, organized, and up-to-date regulatory records and ensures proper traceability of submissions, approvals, and regulatory activities.

Others

Performs other duties that may be given from time to time by the immediate superior or HOD RA/PV/QA.

Qualifications:

• Bachelor'sor master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline. Preferably a Registered Pharmacist (RPh) for pharmaceutical regulatory affairs roles.
• Must be a PRC license holder
• Minimum of 3-5 years experience in PH Regulatory Affairs within the pharmaceutical or biotechnology industry, with at least 1 year hands-on experience with end-to-end experience with Drug Registration and Health Authority Interactions.
• Strong knowledge of ICH guidelines, CTD/eCTD, PIC/S GMP requirements, WHO guidelines, and local regulatory frameworks.
• Strong understanding of GMP, CMC, clinical, bioequivalence, pharmacovigilance, labelling, and lifecycle management.
• Excellent communication, negotiation, and stakeholder management skills.
• Ability to manage multiple projects and work effectively in a fast-paced, multicultural environment.
• Proficiency in Microsoft Office and regulatory information management systems (RIMS/DMS/eCTD platforms) is preferred.

Core Competencies:

• Fluent in English for professional communication.
• Demonstrated interpersonal and influencing skills, with a proven ability to communicate strategic and tactical regulatory issues clearly to management and diverse stakeholders.
• Strong personal development and motivational skills; committed to ongoing professional growth and supporting the growth of others.
• Ability to work independently, manage multiple priorities, and deliver high-quality outcomes in a dynamic, fast-paced, and cross-cultural environment.

Preferred Skills:

• CTD/eCTD dossier preparation
• Lifecycle management
• GMP compliance
• Cross-functional collaboration
• Excellent written and verbal communication