Regulatory Affairs Specialist

2 weeks ago

Manila, National Capital Region, Philippines Melaleuca of the Philippines, Inc. Full time

General Summary

The Regulatory Affairs Specialist is primarily responsible for the company's compliance with all relevant regulations across our product categories. The incumbent will play a key role in developing and implementing regulatory strategies, managing projects, and providing expert guidance to ensure the smooth launch and ongoing marketing of our products. Highly motivated, excellent project management skills, strong communication, interpersonal, and collaboration skills are required for this role.

The role reports directly to the Senior Brand Manager of Melaleuca of the Philippines, Inc.

Principal Responsibilities

Be in charge of the overall regulatory application and registration processes.Act as the technical point person on regulatory concerns, guidelines, and procedures pertaining to cosmetics, food, food supplements, Household/Urban Hazardous Substances (HUHS), etc., issued and carried out by FDA, DENR, Tariff Commission, etc.Prepare and evaluate documents for product registration according to FDA, HUHS, and other regulatory bodies. Facilitate the application and processing of License to Operate (LTO), Certificate of Product Registration (CPR), etc. Ensure that product formulations and other required documents conform to regulatory standards for submission. Review and ensure documents/product dossiers (re: LTO, CPR, and Product Notification) are prepared in accordance with regulatory guidelines. Follow up on product regulatory applications with relevant parties, internal or external. Work closely with the US counterpart on product formula review, advising and contributing as part of the international formula review process. Provide regulatory and legislative guidance, and reviews of relevant authorities & sources by working with the US counterpart. Keep track of near-expiry licenses and prepare documents for renewal. Work with designers, Taiwan, and US counterparts to ensure that product labels are completed and updated with the correct information as needed. Manage and update related departments on the latest regulatory requirements and FDA advisories through regulatory meetings or other channels of communication. Represent the company in handling any post-market surveillance or audit conducted by the regulatory bodies. Keep abreast of local and international legislation, guidelines, and practices, and attend seminars (CCIP/FDA seminars and other business-related seminars) as necessary to stay updated on the latest rules, regulations, and practices. Help conduct product-related training and demonstrations whenever necessary. Perform any other duties commensurate with the job grade as reasonably required from time to time. Supervision of Others Does not supervise others. Knowledge, Skills and Ability Requirements At least 3 years of working experience in regulatory affairs and product registration for Skincare and Cosmetics, Food, Food supplements, Household/Urban Hazardous Substances (HUHS), Medical Devices ad etc. Able to work independently with minimum supervision to support Philippine market. Has experience working with the Food and Drug Administration.Possess comprehensive knowledge on related regulatory requirements for various products.Proficient in the use of Microsoft Outlook, Excel, PowerPoint, Word and Adobe PDF. Required language(s): English, Filipino. Education Requirements Candidate must possess at least Bachelor's/College Degree in Pharmacy.Licensed Pharmacist.

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