Philippines Regulatory Affairs & QA Leader (QP)

Alfasigma; Manila; Presencial; PHP 1 800 000 - 2 800 000; Tempo integral

Resumo da oferta

Alfasigma is seeking a Regulatory Affairs Manager, PV & QA for its Philippine operations. You will lead all Regulatory Affairs, Quality/Pharmacovigilance activities, ensuring compliance with FDA Philippines, ASEAN standards, and Alfasigma policies.

You will manage registrations, LTO/CPR, and act as Local QP for PV, supporting the affiliate transition from distributor to licensed entity. The role requires 7–10 years in regulatory affairs/QA, strong English/Filipino communication, and the ability

Qualificações

• Bachelor's degree in Pharmacy or related Life Sciences; licensed pharmacist in the Philippines.
• 7–10 years in regulatory affairs and/or quality assurance in pharma, multinational exposure preferred.
• Strong knowledge of FDA PH, ASEAN ACTD, and GMP/GDP guidelines.
• Experience with LTO/CPR and site transfers is highly desirable.

Responsabilidades

• Lead regulatory submissions, renewals, variations, and post-approval changes.
• Coordinate with FDA Philippines and regional RA teams for dossiers and GMP documentation.
• Manage QP appointment, QA systems, and product release documentation.
• Oversee pharmacovigilance activities as Local QP for Philippines.
• Support affiliate setup and regulatory lifecycle management across products.

Conhecimentos

Regulatory affairs

Quality assurance

Pharmacovigilance

Leadership

Cross-functional collaboration

Formação académica

Bachelor’s degree in Pharmacy or related Life Sciences

Descrição da oferta de emprego

Alfasigma is seeking a Regulatory Affairs Manager, PV & QA for its Philippine operations. You will lead all Regulatory Affairs, Quality/Pharmacovigilance activities, ensuring compliance with FDA Philippines, ASEAN standards, and Alfasigma policies.

You will manage registrations, LTO/CPR, and act as Local QP for PV, supporting the affiliate transition from distributor to licensed entity. The role requires 7–10 years in regulatory affairs/QA, strong English/Filipino communication, and the ability