GRACE VALENCIA VIRATA

Seasoned Regulatory Affairs and Quality Manager with 19 years of progressive experience in the pharmaceutical and medical device industries. Proven track record in securing regulatory approvals, managing compliance programs, and leading cross-functional teams. Currently manages a high-performing Regulatory and Quality team in the Philippines, driving operational excellence, regulatory strategy, and quality compliance. Leads dossier preparation projects across Southeast Asia, collaborating with global business RA, country RA, and commercial teams. Adept in pharmacovigilance, distributor management, and strategic planning for product registrations and market access. Recognized for industry leadership, innovation, and excellence in customer service and sales performance. Licensed Pharmacist and founding member of PAMDRAP, with strong relationships across government agencies and healthcare organizations.

• Successfully secured Licenses to Operate from the Philippine FDA for both start-up and established companies as importers/distributors of medical devices, drugs, and cosmetics.
• Brings 19 years of regulatory expertise, consistently ensuring full compliance with SOPs, company policies, and government healthcare regulations.
• Led the successful transfer of marketing authorizations from multiple distributors, ensuring uninterrupted business operations.
• Developed and executed strategic plans for new product registrations, license renewals, and post-market changes for pharmaceuticals, medical devices, and cosmetics.
• Conducted internal audits and evaluated distributor partners to ensure alignment with company policies and regulatory requirements.
• Oversaw compliance with local regulations and corporate policies, including the creation and maintenance of SOPs and coordination of Field Corrective Action Plans, CAPA, and management of expired/returned/damaged products.
• Served as Pharmacovigilance contact person for Fresenius Kabi Philippines, Inc. and 3M Philippines, Inc., ensuring timely and accurate safety reporting.
• Holds leadership roles in professional organizations; founding member and current Board of Trustee of the Philippine Association of Medical Device Regulatory Affairs Professionals (PAMDRAP).
• Recipient of the Global Regulatory Award FY20 for customer-centric and innovative contributions.
• Honored with the Southeast Asia Achievement Award FY16 by Medtronic’s CRHF Business Unit.
• Nominated for the Global Regulatory Affairs Excellence Award FY16 at Medtronic Philippines.
• Recognized for exceptional sales performance at 3M Philippines and Zuellig Pharma.

Philippine Association of Medical Device Regulatory Affairs Professionals (Board of Trustee, Chair-IVD)

• Lead a strong Regulatory and Quality team in the Philippines, ensuring compliance with local regulations and corporate standards.
• Currently serve as team lead for a Southeast Asia dossier preparation project, working closely with global business RA, country RA, and commercial teams to ensure timely and compliant submissions.
• Collaborate with cross-functional teams (marketing, supply chain, sales, global manufacturing) to support product registration, importation, and distribution.
• Oversee product registrations (CPR, COE, import permits, compassionate use) and establish licensing schemes across all business units.
• Develop and implement regulatory strategies with SEA RA Director and business units to address market access challenges.
• Maintain strong relationships with the Philippine FDA and other regulatory bodies; represent the company in industry associations, APAC and ASEAN meetings.
• Ensure compliance of distributors and toll manufacturers through audits, inspections, and training.
• Review and approve quality documents, packaging, and promotional materials to meet regulatory and corporate requirements.
• Monitor regulatory changes and provide regular updates to stakeholders.
• Manage department budget and staff development, including training and succession planning.
• Drive company engagement with regulatory authorities on matters related to product complaints, pharmacovigilance and upcoming regulatory frameworks through public consultations

• Servant leadership
• Critical thinking
• Decision Making
• Agile and Results driven
• Coaching