Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist will support iNova’s growth in the Philippines by ensuring product registrations, company licences and pharmacovigilance activities comply with local regulations and global quality standards. This position works closely with internal teams and the Global Patient Safety and Risk Management group to maintain a safe and uninterrupted supply of iNova products.

Key responsibilities

• Register and maintain product registrations and company licences with the Philippine FDA, PDEA and DOH.
• Apply for permits and licences required for product release, warehousing and marketing activities.
• Provide regulatory guidance to internal departments, including formulary inclusion and labelling compliance.
• Coordinate with third‑party service providers to keep product information up‑to‑date in external databases.
• Develop, update and maintain SOPs and regulatory databases, reporting status to the Regulatory Affairs Manager.
• Build and sustain relationships with regulatory agencies and pharmaceutical associations.
• Act as the local pharmacovigilance contact, collaborating with the Global Patient Safety team to monitor, assess and report adverse events in line with SOPs and local requirements.

Required profile

• Dynamic, detail‑oriented professional with experience in regulatory affairs and pharmacovigilance.
• Strong knowledge of Philippine pharmaceutical regulations (FDA, PDEA, DOH).
• Proven ability to work cross‑functionally and communicate regulatory requirements clearly.
• Commitment to regulatory excellence and product safety.

Required skills

• Experience with product registration processes in the Philippines.
• Familiarity with pharmacovigilance reporting and safety surveillance.
• Ability to prepare and manage regulatory documentation and SOPs.
• Competence in maintaining regulatory databases and monitoring records.