The Regulatory Affairs Associate shall provide technical and logistic support to legal and registration activities of the Regulatory Affairs Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.
Responsibilities:
• Handle registration (review and submission) and monitoring of food and food supplements, cosmetics and medical devices
• Represent the company/ Act as liaison officer to the local FDA (for assigned products)
• Assist the RA Head in complying with the local FDA’s regulatory guidelines
• Provide regulatory information through preparation of registration updates, maintenance and update of product information, registration dossiers and regulatory files; submission of updated prescribing information and other updates/ variations in technical information to FDA and includes monitoring of implementation; updating of all product monographs for publication in the local compendia
• Provide technical support to internal and external customers including, but not limited to:
prompt preparation and compilation of additional regulatory requirements in support of marketing thrusts and directions
provision of updated Certificate of Product Registration to business units for inclusion in drugstores, hospital formularies and bidding purposes
accomplishing regulatory reports for submission to RA Head
Assist in the management of regulatory tools and database
• Act as local QPPV (Qualified Person Responsible for Pharmacovigilance)
• Perform other job-related duties and responsibilities as determined by RA Head and/or job-related tasks as needed by the company
Qualifications:
• Bachelor’s/ College Degree in Pharmacy or Industrial Pharmacy (duly registered with the Professional Regulation Commission)
• At least 1-2 years of working experience in regulatory affairs and in the pharmaceutical industry
• Experience in handling Food/ Food Supplements, Cosmetics and Medical Devices is an advantage
• Must have good communication skills (both oral and written) and able to work independently or with very minimal supervision.