
Regulatory Affairs and Quality Assurance Manager
3 days ago
- 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.
- 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.
-
quality management/regulatory affairs
3 days ago
Quezon City, National Capital Region, Philippines DYNA DRUG CORPORATION Full time ₱250,000 - ₱750,000 per yearQuality Management and Regulatory Affairs SupervisorThe Quality Management and Regulatory Affairs Supervisor serves as the Deputy to the Quality Management Manager and holds primary responsibility for the deliverables and outputs of both the Quality Management and Regulatory Affairs sections. This role ensures the timely and accurate registration of the...
-
Regulatory Affairs Manager
2 weeks ago
Quezon City, National Capital Region, Philippines Direct Lines Sales Unltd. Inc. Full time ₱960,000 per yearWe are looking for an experienced and detail-oriented Regulatory Affairs (RA) and Quality Assurance (QA) Manager to lead the implementation of company-wide quality systems and ensure full compliance with regulatory requirements.This critical role involves managing audits, maintaining product quality, overseeing documentation, and serving as the primary...
-
Pharmacist (Regulatory Affairs)
3 days ago
Quezon City, National Capital Region, Philippines John Clements Consultants, Inc. Full time ₱800,000 - ₱1,200,000 per yearAssisting 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 Manager
1 day ago
Makati City, National Capital Region, Philippines Wellesta Buergli Pharma Inc. Full time ₱1,500,000 - ₱3,000,000 per yearJob Summary:The Regulatory Affairs Manager is responsible for ensuring that the company's products meet all regulatory requirements and standards in the markets where they are sold. This role involves managing the regulatory approval process, keeping up to date with regulatory changes, and ensuring compliance with all relevant laws and guidelines. The...
-
Regulatory Affairs Specialist
1 day ago
Quezon City, National Capital Region, Philippines Pascual Consumer Healthcare Corp. Full time ₱900,000 - ₱1,200,000 per yearRegulatory Affairs Specialist:Must be a licensed Pharmacist with at least 2 years experience with regulatory affairs within Pharmaceutical industryAt least 1 year exposure to Pharmacovigilance and FDA promo permit submissionKnowledgeable in regulatory requirements for consumer health productsMust be proficient in MS Word, Excel, and OutlookDetail oriented...
-
Regulatory Affairs Pharmacist
1 day ago
Makati City, National Capital Region, Philippines The Raya Clinic Full time ₱60,000 - ₱120,000 per yearJob Summary:The Regulatory Pharmacist will be responsible for ensuring compliance with Philippine FDA regulations and other applicable laws governing the registration, licensing, distribution, and marketing of pharmaceutical products. The role involves preparing and submitting regulatory dossiers, securing necessary permits, and monitoring regulatory changes...
-
Regulatory Affairs Associate
1 day ago
Makati City, National Capital Region, Philippines pacific surgical inc. Full time ₱1,200,000 - ₱2,400,000 per yearMain 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 Associate
1 day ago
Makati City, National Capital Region, Philippines Transmedic Group Full time ₱900,000 - ₱1,200,000 per yearJob description: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...
-
Regulatory Affairs Associate
3 days ago
Makati City, National Capital Region, Philippines pacific surgical inc. Full time ₱120,000 - ₱180,000 per yearMain 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 Pharmacist
1 week ago
Quezon City, National Capital Region, Philippines New Bilrey Construction & Development Corporation Full time ₱240,000 - ₱360,000 per yearWe are looking for a Licensed Pharmacist with a passion for regulatory work to join our team as a Regulatory Affairs Specialist. In this role, you'll handle permits, licenses, and compliance with FDA and other government agencies—ensuring our operations run smoothly and legally.What You'll Do:Prepare, process, and renew permits, licenses, and...