Regulatory Pharmacist

6 days ago

Pasay, Philippines George Optical Inc. Full time

About the role

We are looking for aRegulatory Affairs and Quality Assurance Manager to lead regulatory compliance and quality assurance across our operations. Based in Pasay City, this role ensures all products meet FDA and ISO standards while supporting business growth in the Philippine market.

Key Responsibilities
  • Ensure valid FDA certifications (CPR, LTO) for all products and registrations
  • Oversee regulatory processes: new applications, renewals, variations, and promo permits
  • Represent the company in FDA inspections (Medical Device and HUHS)
  • Lead ISO compliance and quality audits for manufacturing and distribution
  • Develop and maintain SOPs aligned with FDA and ISO standards
  • Manage company-wide document control through Quality Management System
  • Act as final approver for after-sales complaints and ensure internal reporting
  • Liaise with regulatory counterparts and assist in government inspections
  • Ensure compliance with the National Privacy Commission
Qualifications
  • Licensed Pharmacist with a BS in Pharmacy
  • 3–5 years experience in Regulatory Affairs and Quality Assurance
  • Background in manufacturing or distribution (ISO-certified preferred)
  • Proficient in FDA, ISO, and OMB permit regulations
  • Strong communication, leadership, and analytical skills
  • Proficient in Microsoft Office and regulatory software
#J-18808-Ljbffr

  • Regulatory Pharmacist

    1 day ago

    Pasay P, Philippines AMBICA INTERNATIONAL CORPORATION Full time ₱250,000 - ₱300,000 per year

    Job DescriptionRegulatory Pharmacist ensures that the company complies with applicable FDA and other regulatory-related government entities regulations on licenses, technical documents, and product registrations. They are also responsible for the preparation, evaluation, and submission of Initial applications. This is a desk-based role, involving the close...

  • Regulatory Case Specialist

    2 weeks ago

    Pasay, National Capital Region, Philippines beBeeRegulatory Full time ₱4,500,000 - ₱7,000,000

    Job Title: Regulatory Case SpecialistThe Regulatory Case Specialist will be responsible for ensuring the accurate and timely processing of case data.Responsibilities: Data entry of vigilance cases in relevant databases according to relevant conventions. Quality control of vigilance cases and other documents associated with safety reports. Medical review...

  • Quality Control Pharmacist

    3 weeks ago

    Pasay, National Capital Region, Philippines Ambica International Corporation Full time

    Recruitment Supervisor at Ambica International CorporationJob Description:Responsible for verifying the activities done during the In-house inspection of finished products and ensuring FDA requirements and company objectives are met.Monitors compliance of all staff with the requirements of GMPEnsures that the products comply with the specifications as per...