Company Description Sydenham Laboratories, Inc. (SLI) is a PIC/S GMP-compliant, ISO 9001:2008 and HACCP-certified pharmaceutical company specializing in the development and manufacture of healthcare products. The company produces oral drug preparations in tablet, capsule, syrup, and powder for suspension forms, along with food supplements in similar dosage forms. Non-penicillin, penicillin, and cephalexin-based products are manufactured in separate facilities with HEPA-filtered clean rooms to prevent cross-contamination and ensure product quality. Founded in 1971 by Dr. Eduardo R. dela Cruz, SLI upholds a strong legacy of clinical excellence and patient-focused care inspired by its namesake, Dr. Thomas Sydenham, a pioneer of modern clinical medicine.
Role Description This is a full-time, on-site Regulatory Affairs Pharmacist role based in Dasmariñas. The Regulatory Affairs Pharmacist will prepare, review, and submit registration dossiers and product variations in compliance with national and international regulatory requirements. The role includes maintaining up-to-date product licenses, monitoring regulatory changes, and ensuring labeling, packaging, and promotional materials meet current regulations. The pharmacist will collaborate with quality assurance, production, R&D, and marketing teams to support product development and lifecycle management from a regulatory perspective. Daily responsibilities also include managing regulatory documentation, responding to regulatory authority queries, supporting audits and inspections, and contributing to continuous improvement of regulatory processes and standard operating procedures.
Qualifications
- Strong foundation in Pharmacy with a valid pharmacist license and experience in a pharmaceutical, regulatory, or quality-focused setting.
- Demonstrated expertise in Regulatory Affairs, including preparation and submission of dossiers and management of product registrations.
- Thorough understanding of Regulatory Compliance and Regulatory Requirements relevant to pharmaceuticals and food supplements.
- Effective Communication skills, including clear technical writing, documentation, and cross-functional collaboration.
- High attention to detail, strong organizational and time-management abilities, and proficiency with standard office and documentation software.
- Knowledge of GMP, ISO, and HACCP standards; experience with audits or inspections is an advantage.
- Ability to work on-site in Dasmariñas and collaborate in a structured, process-driven environment.
- Bachelor's degree in Pharmacy or equivalent; prior experience in regulatory affairs within a manufacturing environment is preferred.
