Regulatory Affairs & PV Lead, Philippines

Alfasigma group; Manila; On-site; PHP 1,500,000 - 2,100,000; Full time

Job summary

Alfasigma Philippines invites applications for a Regulatory Affairs Manager, PV & QA to lead regulatory submissions and ensure compliance with FDA Philippines. You will serve as Local Qualified Person for Pharmacovigilance and oversee quality systems in collaboration with regional teams.

The role demands 7–10 years in regulatory or QA in pharma, a licensed pharmacist, and strong English/Filipino communication in a matrix organization. Italian exposure is a plus and a competitive package awaits.

Qualifications

• Bachelor’s or higher in Pharmacy, Chemistry or Life Sciences.
• Licensed Pharmacist in the Philippines (required for QP).
• 7–10 years in Regulatory Affairs and/or QA in pharma, multinational preferable.
• Experience with product registration, LTO/CPR, GMP/GDP, and audits.
• Strong knowledge of FDA Philippines procedures, ACTD, and ASEAN variations.
• Experience with site transfers or affiliate setup is desirable.
• Excellent English and Filipino; Italian exposure is a plus.
• High integrity and ability to work independently in a matrix org.

Responsibilities

• Lead regulatory submissions (new registrations, renewals, variations, site transfers).
• Liaise with FDA Philippines and ensure local regulatory compliance and timelines.
• Maintain LTO, CPR, PDR, CPP dossiers and related documents.
• Coordinate with regional RA teams and partners for dossier prep and GMP docs.
• Ensure approved labeling changes and regulatory renewals are implemented.
• Manage registrations planning for pipelines and new products.
• Monitor ASEAN regulatory developments and inform stakeholders.

Skills

English proficiency

Filipino language

Licensed Pharmacist

Regulatory affairs

Quality assurance

GMP/GDP

Education

Pharmacy degree

Job description

Alfasigma Philippines invites applications for a Regulatory Affairs Manager, PV & QA to lead regulatory submissions and ensure compliance with FDA Philippines. You will serve as Local Qualified Person for Pharmacovigilance and oversee quality systems in collaboration with regional teams.

The role demands 7–10 years in regulatory or QA in pharma, a licensed pharmacist, and strong English/Filipino communication in a matrix organization. Italian exposure is a plus and a competitive package awaits.