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...

The Regulatory Pharmacist is responsible for managing and ensuring the compliance of pharmaceutical products with all applicable regulatory requirements. This position involves preparing, submitting, and maintaining necessary documentation for the registration and approval of veterinary medicines, vaccines, and related products. The Regulatory Pharmacist...

· 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. ,...

Job Summary:As a Compliance Manager, you will be responsible for ensuring the company's full compliance with regulatory requirements, including those set by the FDA, ISO, and other relevant industry authorities. Your role includes developing, implementing, and maintaining compliance policies, managing documentation, and fostering collaboration across...

The PED Staff is responsible for the overall maintenance and operational efficiency of the building facility. This role ensures that all building systems are functioning properly, regulatory requirements are met, and tenant construction and utilities are effectively managed. The PED Staff also coordinates with subcontractors and internal teams to resolve...

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...

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,...