quality management/regulatory affairs

Job ResponsibilitiesDevelop, 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...

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...

We 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...

Job 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: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...

We 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...

Regulatory Specialist:· Must be a licensed Pharmacist with at least 2 years experience with regulatory affairs within Pharmaceutical industry· At least 1 year exposure to Pharmacovigilance and FDA promo permit submission· Knowledgeable in regulatory requirements for consumer health products· Must be proficient in MS Word, Excel, and Outlook· Detail...

Job 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...

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...

Job 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...