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...

OVERVIEW:The Regulatory Affairs Officer/Quality Officer is responsible for ensuring that the products and practices comply with industry regulations and standards. Maintains the high quality of the products and protects the safety of customers by ensuring that the goods delivered are at its best condition at all times.MINIMUM QUALIFICATION:Graduate of a...

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...

JOB OVERVIEW:The Regulatory Affairs Specialist is responsible for managing all regulatory affairs, documentation, and follow-up transactions with the FDA and LGUs. He/She ensures that all company products comply with legislative requirements, secures and maintains updated permits and licenses, and oversees Grifols logistics.TASK LIST:RA CompliancePermits &...

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...

QUALITY ASSURANCE:Responsible for the final release of products in the absence of Sr. RA/QA Manager.Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality StandardsSupervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in...

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...