Regulatory Affairs Manager, PV&QA

Alfasigma; Manila; On-site; PHP 1,800,000 - 2,800,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

Quality assurance

Pharmacovigilance

Leadership

Cross-functional collaboration

Education

Bachelor’s degree in Pharmacy or related Life Sciences

Job description

Purpose of the role

As Regulatory Affairs Manager, PV & QA you will lead all Regulatory Affairs and Quality/Pharmacovigilance (QP) functions for Alfasigma’s Philippine operations, ensuring full compliance with FDA Philippines, ASEAN regulatory standards, and Alfasigma global quality policies. In this position you will play a pivotal role in managing product registrations and lifecycle management, regulatory variations, LTO and CPR applications and maintenance, and fulfillment of responsibilities as the designated Qualified Person (QP) and Local Qualified Person for Pharmacovigilance (QPPV), while supporting the affiliate transition from a distribution/agency model to a fully licensed affiliate.

Your role

Regulatory Affairs

• Manage and oversee all regulatory submissions (new registrations, renewals, variations, site transfers, and other post-approval changes) for applicable pharmaceutical and healthcare products.
• Liaise directly with FDA Philippines and ensure compliance with timelines, documentation, and local requirements.
• Maintain and update LTO, CPR, PDR, CPP, and related regulatory dossiers to ensure continued compliance throughout the product lifecycle.
• Coordinate with regional/global RA teams and local partners (e.g., re-packers, distributors, toll manufacturers) for dossier preparation and GMP documentation.
• Ensure timely implementation of approved labeling, artwork changes, and regulatory renewals.
• Manage registration planning for pipelines or new products aligned with marketing and business objectives.
• Monitor ASEAN regulatory developments and communicate regulatory intelligence to internal stakeholders.

Qualified Person / Quality Assurance

• Act as local QP ensuring product release, compliance with cGMP, GDP, and local QA standards.
• Establish, maintain, and implement Quality Management System (QMS) in line with Alfasigma corporate and Philippine FDA requirements.
• Review and approve product release documentation, deviations, and batch records (from Italy or local re-packers).
• Manage product complaints, recalls, deviations, CAPA, and other quality events in accordance to established procedures.
• Qualify and conduct audits of local partners (re-packers, distributors, logistics providers, and other GxP service providers) to ensure compliance.
• Oversee stability study coordination, import testing, and sample management as needed.
• Lead training programs on regulatory compliance, GMP/GDP, and for affiliate staff.

Strategic & Cross-Functional

• Support affiliate set-up by preparing regulatory dossiers for QP appointment, LTO of affiliate, and transition of product ownership from distributor to affiliate.
• Provide regulatory and quality input to commercial, supply chain, and business planning decisions (e.g., timing of launch, supply price vs. market authorization).
• Collaborate with Legal, Supply Chain, Medical, and Marketing teams on product life cycle and compliance aspects.
• Represent Alfasigma in regulatory forums and local industry associations (e.g., PHAP, IPAP).

Pharmacovigilance

• Serve as the Local Qualified Person for Pharmacovigilance for the Philippines
• Act as the primary point of contact for FDA Philippines on all pharmacovigilance matters
• Ensure that the pharmacovigilance system complies and implemented according to FDA guidelines and Alfasgima Global PV procedures
• Ensure timely collection and reporting of safety reports to Global PV team
• Support local implementation of safety variations, risk management plans, and aRMMs, and safety aggregate reports.
• Maintain oversight of local PV activities, ensuring appropriate documentation, training, compliance monitoring, and inspection readiness
• Develop, maintain, and update local Standard Operating Procedures (SOPs)/Work Instructions (WIs) for Pharmacovigilance ensuring alignment with both global and local requirements
• Conduct PV training and awareness sessions for the Philippines team on relevant pharmacovigilance topics, as applicable
• Maintain required PV records and documentations to ensure readiness for audit and inspection
• Cooperate and support the Global PV Team to ensure the global PV compliance

Who you are

• Bachelor’s or higher degree in Pharmacy, Chemistry, or related Life Sciences discipline.
• Must be a Licensed Pharmacist in the Philippines (mandatory for QP appointment).
• Minimum 7–10 years’ experience in Regulatory Affairs and/or Quality Assurance within the pharmaceutical industry, preferably with multinational exposure.
• Proven experience in product registration, LTO/CPR maintenance, GMP/GDP, and audit management.
• Deep understanding of FDA PH procedures, ASEAN Common Technical Dossier (ACTD), and ASEAN variations guidelines.
• Experience managing site transfer or affiliate setup projects is highly desirable.
• Excellent communication skills in English and Filipino; Italian language exposure a plus.
• High integrity, attention to detail, and ability to operate independently in a matrix organization.