Regulatory Affairs Pharmacist

TheRegulatory Affairs Pharmacistensures our company's FDA compliance with all relevant regulations across our Cosmetics products. You will play a key role in developing regulatory strategies, inspection compliance, FDA correspondence and registration of our products. Knowledgeable in FDA rules and policies, strong written and oral communication, organization...

Bachelor's degree in Pharmacy with an active PRC license.Minimum of 1–2 years of relevant experience in regulatory affairs, specifically in handling drugs, food, and medical devices.Strong negotiation and selling skills are required.Background in managing food supplements, cosmetics, and medical devices is a plus.Excellent verbal and written communication...

Duties and ResponsibilitiesRegulatory Submissions and Filings:Assist in the preparation and submission of regulatory documents, including applications for product registration, licenses, and other regulatory approvals required by the FDA Philippines and other relevant agencies.Prepare and review regulatory dossiers for product registrations, renewals,...

The Regulatory Affairs Associate is responsible for supporting the regulatory affairs team in ensuring the company's products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA) Philippines, and...

Job Objective:The Regulatory Affairs Associate is responsible for supporting the regulatory affairs team in ensuring the company's products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA)...

Duties and ResponsibilitiesRegulatory Submissions & FilingsSupport in preparing and submitting regulatory documents, including applications for product registrations, licenses, and other approvals required by the FDA Philippines and related agencies.Draft and review dossiers for product registration, renewals, variations, and other filings.Monitor submission...

QUALITY ASSURANCE:Responsible for the final release of products in the absence of Sr. RA/QA Manager.Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality StandardsSupervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in...

Prepares and check submission of License to Operate renewal and other inter-related regulatory correspondence with FDA.OPERATIONSEnsures that formulation conforms to FDA standards and is within the approved limit.Ensures that labels of new and existing items conform to FDA Standards.Checking of e-Portal for newly approved CPN/CPR's. Download, file and update...

Job DescriptionPrepare and check submissions of License to Operate, Cosmetic Notifications, CPRs, and other related regulatory correspondence with FDA.Check product labels conforming to ACD Standards.Ensure that all FDA license, certificates, and permits are updated and valid.Coordinate with manufacturers for Product Information File for filing based on...

1. Regulatory Submissions and FilingsPrepare and submit regulatory documents for product registration, renewals, variations, and licensing as required by the FDA Philippines and other regulatory agencies.2. Regulatory Compliance and GuidanceProvide regulatory guidance to cross-functional teams (e.g., R&D, QC, manufacturing) to ensure products and processes...