Regulatory Affairs Manager, PV&QA

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

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

A. 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.

B. 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.

C. 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).

D. 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.

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
 We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.