MAYLEEN ABARICO
San Mateo,,RIZ
Summary
Regulatory professional with solid track record in managing regulatory submissions and compliance. Known for strong focus on collaborative team efforts and achieving results, adaptable to changing regulatory landscapes. Expertise in regulatory strategy, dossier preparation, and cross-functional teamwork, ensuring successful product approvals.
Overview
17
17
years of professional experience
Work History
Senior Regulatory Affairs Manager- SEA
Phibro Animal Health
01.2021 - Current
- Responsible for all regulatory affair matters of Indonesia, Bangladesh, Malaysia and Philippines.
- Plan, organize and submit various regulatory data packages and complete registration processes in timely manner.
- Kept abreast of evolving industry trends, allowing the company to adapt quickly to changes in the regulatory landscape.
- Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
- Negotiated favorable terms during interactions with regulators, fostering positive relationships that facilitated smoother approval processes.
- Implemented change control systems for efficient tracking and management of document revisions related to regulatory submissions.
- Actively participated in industry conferences and workshops, enhancing professional networks while staying up-to-date on best practices in regulatory affairs management.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Served as an authoritative resource on all regulatory matters, providing clear guidance to stakeholders at all levels within the organization
SEA Export & Regulatory Officer
Virbac Phils, Inc
12.2014 - 12.2020
- Key person to coordinate with the manufacturers to SEA distributors: Singapore, Malaysia, Myanmar and Indonesia regarding regulatory affairs requirement of each country
- Played an instrumental role in supply chain by giving updated information on custom requirements and process.
- Managed the licensing process for new products, navigating complex regulatory frameworks with precision and accuracy.
- Developed strong working relationships with regulators, enhancing trust and cooperation in addressing compliance matters.
- Ensure that the imported products reach country destination with correct importation requirements
Company Pharmacist & Marketing Asst.
Virbac Phils., Inc.
01.2008 - 01.2014
- Crucial link between the manufacturer and local team to ensure that all regulatory requirements are well defined.
- Plan, request and prepare dossier based on local registration requirements.
- Provided expert guidance during development of new products.
- Manage the warehouse to ensure that the product is properly stored according to the country's local agency and manufacturer's requirement
- Involve in conceptualization, implementation and monitor marketing activities.
Education
Bachelor of Pharmacy -
Centro Escolar University
01.2000
Skills
- Regulatory submissions
- Regulatory strategy
- Labeling compliance
- Regulatory compliance
- Pharmacovigilance
- Team player
- Adaptable
- Leader
- Communication
- Interpersonal skills
Languages
English
Filipino
Religion
Christian
Personal Information
Marital Status: Married
Children
2
Affiliations
- Vice President - Philippine Association of Pharmacist in Veterinary Industry ( 2021-2023
- Member- Philippine Association of Pharmacist in Pharmaceutical Industry, 2023- Present
- Member of TWG Phils. - Asean Animal Health Association
Timeline
Senior Regulatory Affairs Manager- SEA
Phibro Animal Health
01.2021 - Current
SEA Export & Regulatory Officer
Virbac Phils, Inc
12.2014 - 12.2020
Company Pharmacist & Marketing Asst.
Virbac Phils., Inc.
01.2008 - 01.2014
Bachelor of Pharmacy -
Centro Escolar University
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