FDA Regulatory Staff

Position Summary:The QA/Regulatory Specialist is responsible for ensuring that products, services, and processes comply with internal and external quality standards, as well as government and industry regulations. This role involves maintaining documentation, conducting audits, managing regulatory submissions, and working closely with cross-functional teams...

This position requires at least a LICENSE PHARMACIST.Must have a good understanding of GDocP, GLP, and GMP.Experience in research, laboratory testing, manufacturing process, clinical trials, or QPIRA is an advantage.Responsible for Product registration, license renewals, periodic updates, and registrations to regulatory agencies in all applicable.Regulatory...

Graduate of BS in Pharmacy or any related courses.With experience in processing regulatory licenses (FDA and BAI).Gathering, evaluating, organizing, managing and collating information in a variety of formats.Ensures compliance with the regulatory agency for medicines and healthcare products.Maintaining familiarity with company product ranges.Planning,...

About the Role:We are looking for a dedicated Compliance Specialist to help ensure that all company processes and documentation comply with GMP, GDP, FDA, Halal, FSSC, and other industry standards. This role plays a key part in maintaining our commitment to quality, regulatory compliance, and operational excellence.Key Responsibilities:Monitor and maintain...

· This position requires a license at least a graduate of BS Chemistry, BS Microbiology, BS Pharmacy, or any related courses.· He/she must understand the interactions between the company's various regulatory and GMP requirements.· responsible for maintaining the Company's Archives. He/she prepares, issues and keeps all manufacturing process documents. ,...

upervise and coordinate maintenance staff across electrical, mechanical, plumbing, and structural systems.Develop and implement preventive maintenance schedules and procedures.Monitor and ensure compliance with safety, environmental, and regulatory standards (Federal, State, and local).Manage work orders, prioritize tasks, and allocate resources...

Responsible for the following:Technical Request - Coordinates with principal suppliers on documentation requests (clients, FDA, regulatory requirements, inquiries and complaints); Review customers' raw material specificationRegulatory (FDA compliance) - Ensures compliance with FDA requirements (LTO, CPRs, and other food authorization certificates)Product...

Ensures compliance and assist in the implementation of Quality Management System (QMS), compliance to regulatory requirements, and GxP Standards (e.g. GDSP, GMP, GCP) as applicableInitiate and implement quality initiatives and programs for continual improvementProvides guidance to operational areas to ensure robust quality systemEffectively write, review,...

JOB SUMMARYProvides administrative and technical support to Quality Management Department to ensure adherence of the company's services, processes and procedures to relevant statutory and regulatory standards.QUALIFICATIONSBachelor's degree in any related fieldAt least eight (8) hours of awareness training on ISO 9001:2015Familiar with ISO 9001:2015 QMS...

MediWalk is looking for a driven and dependable Supply Chain Officer who can take full ownership of our day-to-day supply chain and logistics operations — from importation and inventory management to compliance and delivery coordination.This role is both strategic and hands-on, ensuring that every process — securing permits, tracking shipments, managing...