Regulatory Affairs Quality System Specialist

This position involves managing regulatory submissions, maintaining compliance documentation, and liaising with regulatory agencies to facilitate product approvals. The ideal candidate will possess strong knowledge of regulatory affairs, attention to detail, and the ability to navigate complex regulations in the pharmaceutical, biotechnology, or medical...

About the Role This position involves managing regulatory submissions, maintaining compliance documentation, and liaising with regulatory agencies to facilitate product approvals. The ideal candidate will possess strong knowledge of regulatory affairs, attention to detail, and the ability to navigate complex regulations in the pharmaceutical, biotechnology,...

About the RoleThis position involves managing regulatory submissions, maintaining compliance documentation, and liaising with regulatory agencies to facilitate product approvals. The ideal candidate will possess strong knowledge of regulatory affairs, attention to detail, and the ability to navigate complex regulations in the pharmaceutical, biotechnology,...

Graduate of any four (4) year course. Bachelor’s degree in Life Sciences or a related field; advanced degree preferred. Extensive experience in regulatory affairs, including drug development, manufacturing, and commercialization. Proven leadership and project management capabilities. Experience working across multiple regulatory functions and strong...

Senior Regulatory Specialist Ensure that the Regulatory Department is doing their assigned duties and responsibilities Direct reporting to General Manager and Regulatory Affairs Head from parent company Food Registrations (FDA) – preparation of documents and actual sample for submission Initial Applications Renewal Applications Reapplications (submissions...

Responsibilities:Revalidate CPR Database: Ensure database accuracy, including compliance and Bromide Review.Build MNC Nutrifacts Database: Create a reference for nutrient profiling, claims, and DepEd order compliance.Prepare Positive Claims Repository: List authorized health/nutrition claims with details.Compile Competitor Data: Gather competitor product...

Regulatory Pharmacist Rivermed, Inc Salary: ₱25-30K (Monthly) On-site - Pasig Experience: 1-3 Yrs Exp Bachelor Full-time Job Description Prepare, review, and submit product registration dossiers to the FDA (Food and Drug Administration) and other relevant regulatory bodies. Ensure all products comply with local laws and regulations, including labeling,...

Job SummaryThe Regulatory Specialist ensures that the company complies with all applicable FDA regulations on licenses, product registration, internal and external audit and inspection, technical documentation and monitoring and trainings on product knowledge, pharmacovigilance, Good Storage and Distribution Practices, Current Good Manufacturing Practice,...

Key Responsibilities Handle product registration, renewal, and variation applications for submission to the FDA and other relevant agencies. Ensure compliance with all applicable pharmaceutical and medical device regulations. Prepare, review, and maintain regulatory documents, licenses, and certificates. Coordinate with internal departments, manufacturers,...

QUALIFICATIONS:Licensed PharmacistPreferably with at least one year of experience in regulatory affairs.Knowledge of ACTD is an advantage.DUTIES & RESPONSIBILITIES:Responsible for the review and submission of drug product dossiers.Responsible for reviewing and submitting GMP dossiers.Responsible for product selection from existing partner...