Regulatory Affairs Officer

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...

Job Overview/ Key Responsibilities:Documentation: Prepare and maintain Product Information Files; file and organize FDA-related documents (CPRs, CPNs, LTOs, permits, contracts, audit findings, etc.); monitor license renewals; generate and monitor GS1 barcodes; ensure retention labels and LTO documents are FDA-compliant.Operations: Monitor and track...

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...

TheRegulatory Affairs Pharmacistensures our company's FDA compliance with all relevant regulations across our Cosmetics products. You will play a key role in developing regulatory strategies, inspection compliance, FDA correspondence and registration of our products. Knowledgeable in FDA rules and policies, strong written and oral communication, organization...

Key Responsibilities:1. Product Registration and CompliancePrepare, submit, and monitor applications for product registration, renewal, and amendments with the Food and Drug Administration (FDA) and other relevant agencies.Maintain an updated tracker of all regulatory documents, permits, and certificates.Ensure product labels, packaging, and claims are...

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 &...

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...

Quality 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...