Regulatory Pharmacist
# Regulatory Pharmacist **Interchemex Laboratories, Inc.** · Las Piñas · `On-site` 🕒 **Статус:** *Опубликовано: вчера* · *Источник: Indeed* --- ### About the Role Qualifications: Bachelor's Degree in Pharmacy. Must be a Registered Pharmacist (RPh) in the Philippines. Preferably with 1–3 years of experience in Regulatory Affairs, particularly in pharmaceutical, food supplement, or related industries. Experience in FDA product registration and regulatory submissions is an advantage Key Responsibilities : Prepare, compile, review, and submit applications for FDA product registration, renewal, variations, amendments, and other regulatory applications for pharmaceutical products and food supplements. Prepare and maintain regulatory documents and dossiers in accordance with applicable FDA requirements and guidelines. Review product formulations, specifications, labels, packaging materials, product information, and other technical documents for regulatory compliance. Coordinate with FDA, Quality Assurance, Quality Control, Production, R&D, Supply Chain, and other departments regarding regulatory requirements and applications. Monitor the status of regulatory applications and ensure timely submission of additional documents, responses, and compliance requirements. Prepare responses to FDA deficiencies, queries, notices, and requests for additional information. Monitor changes in FDA regulations, administrative orders, circulars, memoranda, and other applicable regulatory requirements, and assess their impact on company products and operations. Maintain an updated database and monitoring system for product registrations, licenses, permits, certificates, and regulatory deadlines. Support the preparation and maintenance of documents related to GMP compliance, manufacturing licenses, and other establishment-related regulatory requirements. Assist in regulatory activities related to post-marketing surveillance, product complaints, recalls, safety-related requirements, and other post-registration activities, as applicable. Review promotional, advertising, labeling, and other product-related materials for regulatory compliance when required. Coordinate with manufacturing and technical teams to ensure that proposed product changes are properly assessed for regulatory impact before implementation. Provide regulatory assessment and recommendations for new products, product changes, manufacturing changes, and other business initiatives. Maintain organized and accurate regulatory records and ensure that all submissions and supporting documents are properly filed. Assist during FDA inspections, regulatory audits, and other regulatory activities as assigned. Perform other regulatory-related tasks that may be assigned by the Regulatory Affairs Manager or Head of Regulatory Affairs. Pay: Php30,000.00 - Php35,000.00 per month Benefits: Additional leave Company events Employee discount Free parking Health insurance On-site parking Opportunities for promotion Paid training Pay raise Work Location: In person
Наблюдалась 2026-09-22, впервые 2026-09-21, источник — Indeed.