Regulatory Affairs and Quality Assurance Manager

2 days ago

Quezon City, National Capital Region, Philippines QuickStart Solutions Full time $90,000 - $120,000 per year
Job Responsibilities
  • Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO, FDA, and other applicable standards.
  • Conduct internal and external audits to assess compliance and drive corrective/preventive actions (CAPA).
  • Manage product quality issues, including customer complaints, deviations, and non-conformances.
  • Ensure regulatory compliance across all operational areas, including product registration, labeling, and documentation.
  • Act as the primary contact with regulatory agencies for inspections, audits, and product submissions.
  • Oversee supplier qualification and monitoring to ensure quality of raw materials and services.
  • Provide regulatory and quality guidance to cross-functional teams throughout the product lifecycle.
  • Train and lead QA/RA team members, fostering a strong culture of quality and compliance.
Job Qualifications
  • Bachelor's degree in Pharmacy, Life Sciences, Engineering, or a related field (Master's preferred).
  • 5+ years of experience in Quality Assurance and/or Regulatory Affairs, preferably in a regulated industry (pharma, medical devices, cosmetics, or food).
  • Strong knowledge of regulatory standards such as FDA, EMA, ISO 13485, GMP, and other applicable regulations.
  • Experience managing audits and inspections, including interactions with regulatory authorities.
  • Proficient in quality tools and systems, such as CAPA, risk management, and document control software.
  • Excellent communication skills, both written and verbal, for effective collaboration and regulatory correspondence.
  • Strong leadership and project management skills, with experience in team supervision and cross-functional coordination.
  • Analytical and problem-solving abilities, with a detail-oriented and proactive approach to compliance.

  • Pharmacist (Regulatory Affairs)

    2 days ago

    Quezon City, National Capital Region, Philippines John Clements Consultants, Inc. Full time $104,000 - $130,878 per year

    Assisting in the preparation and submission of documentation required for FDA drug registration and MAH (Marketing Authorization Holder) license acquisition.Coordinating with regulatory consultants throughout the licensing process to ensure compliance with relevant regulations.Supporting legal and regulatory compliance efforts, including proper documentation...

  • Regulatory Affairs Associate

    2 days ago

    Makati City, National Capital Region, Philippines pacific surgical inc. Full time ₱600,000 - ₱1,200,000 per year

    Main FunctionA Regulatory Affairs Associate is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under government regulations and ensure compliance of the company to Quality Safe Health and Environment policies and...

  • Regulatory Affairs Specialist

    5 days ago

    Makati City, National Capital Region, Philippines beBeeRegulatory Full time ₱800,000 - ₱1,200,000

    Regulatory Affairs SpecialistThis role acts as an end-to-end specialist in regulatory management of multi-regional, regional and national dossiers for assigned clusters/countries/therapeutic areas/products, both initial registration applications and ongoing lifecycle management through to product withdrawal. The successful candidate will be responsible for...

  • Regulatory Affairs Manager

    2 days ago

    Mandaluyong City, National Capital Region, Philippines Brady Pharma Inc. Full time $40,000 - $60,000 per year

    Job descriptionDuties and Responsibilities in Regulatory AffairsEvaluate ASEAN documents for registration of pharmaceutical products at FDA.Evaluate and check final submissions of documents for product registration of medical devices, cosmetics, and food supplements.Coordinates with the foreign supplier for the updates in the regulations and other...

  • Regulatory Affairs Specialist

    2 days ago

    Caloocan City, National Capital Region, Philippines Exxel Prime International Trading Inc. Full time $40,000 - $60,000 per year

    Job Title: Regulatory Affairs SpecialistDepartment: Technical ServicesReports To: Technical Services Manager / Technical Services SupervisorLocation: #20 Corner Rose St., Reparo Rd., Barangay 161, Baesa, Caloocan CityWork Setup: On-siteEmployment Type: Probationary (5 months)Job Summary:The Regulatory Affairs Specialist is responsible for ensuring that all...

  • Regulatory Affairs Pharmacist

    2 days ago

    Quezon City, National Capital Region, Philippines Sunfu Solutions, Inc. Full time ₱25,000 - ₱300,000 per year

    Join us to make an impact in public health in our country We serve and give solutions to the healthcare sector and we are devoted to bringing quality medical machines to improve lives and strengthen local healthcare capacity building.Qualifications:Candidate must be a licensed Pharmacist.Work experience having registered medical devices and supplies or drugs...

  • Regulatory Affairs Assistant

    2 days ago

    Mandaluyong City, National Capital Region, Philippines RMG Hospital Supply Full time $40,000 - $50,000 per year

    Responsibilities Support Regulatory Officer in processing over-all legal requirements of the company activities such as production registration, renewals, variations, and other regulatory concerns. Assist in liaising with regulatory authorities and ensuring that the quality standards are met, and submissions meet strict deadlines. Provide...

  • Regulatory Affairs Professional

    4 days ago

    Makati City, National Capital Region, Philippines beBeeCompliance Full time ₱900,000 - ₱1,200,000

    Regulatory Compliance SpecialistThis role is responsible for ensuring that all operations meet legal requirements.Key Responsibilities:Oversee customs compliance and regulatory affairs to guarantee seamless operations.Collaborate with cross-functional teams to streamline processes and enhance efficiency.Stay ahead of industry trends and changes in...

  • Manager Public and Regulatory Affairs

    2 days ago

    Makati City, National Capital Region, Philippines OceanaGold Full time $90,000 - $120,000 per year

    Company Description OceanaGold is a growing mid-tier gold and copper producer listed on the Toronto Stock Exchange (TSX). With four operating mines—Haile in the USA, Didipio in the Philippines, and Macraes and Waihi in New Zealand—we are committed to safe, responsible mining that generates strong returns and supports sustainable development. Our...

  • Business & Regulatory Affairs Manager (Mandarin)

    2 days ago

    Makati City, National Capital Region, Philippines OCIC Consulting Int'l. Inc. Full time $40,000 - $80,000 per year

    Business & Regulatory Affairs ManagerFull-Time | On-site | Makati CityWe are seeking a highly driven and detail-oriented Business & Regulatory Affairs Manager to lead our business development efforts, oversee client relations, and ensure full compliance with Philippine licensing and regulatory requirements.If you have strong leadership skills, thrive in a...