Regulatory Affairs Associate
7 days ago
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 ensuring that all products meet the necessary approval processes for marketing in the country. Regulatory 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, variations, and other regulatory filings. Monitor the progress of product submissions and track submission deadlines to ensure timely filings. Regulatory Compliance and Guidance Provide regulatory advice to internal teams (e.g., R&D, manufacturing, quality control) to ensure product development and manufacturing processes comply with local regulations. Ensure that the company’s products, labeling, advertising, and promotional materials meet Philippine regulatory requirements. Monitor changes in regulatory laws and guidelines in the Philippines and update internal teams on new or revised requirements. Communication with Regulatory Authorities Act as a liaison between the company and local regulatory authorities, including the FDA Philippines, Department of Health (DOH), and other relevant government bodies. Assist in preparing responses to queries or requests from regulatory agencies and handle follow-up on submissions. Support the regulatory team during audits or inspections by regulatory authorities. Post‑Market Surveillance and Compliance Assist in post‑market surveillance activities, ensuring products remain compliant after launch in the market. Coordinate the preparation of periodic reports, including Adverse Event Reports (AERs) , Periodic Safety Update Reports (PSURs) , and other required documentation. Support activities related to product recalls, if necessary, and ensure compliance with the regulatory authorities’ requirements for recall procedures. Documentation and Record Keeping Maintain accurate and organized records of regulatory submissions, correspondence, and approvals. Assist in ensuring that regulatory documents are updated and accessible for audits, inspections, and regulatory compliance reviews. Keep detailed records of the company’s interactions with the FDA Philippines and other regulatory bodies. Market Intelligence and Regulatory Research Stay updated on local regulatory changes, trends, and industry news to ensure the company remains compliant with evolving regulations. Research and analyze local regulatory requirements for new products, product changes, or market expansions. Cross‑functional Collaboration: Work closely with internal departments such as legal, marketing, R&D, and manufacturing to ensure that products are developed, produced, and marketed in compliance with regulatory standards. Assist in the preparation of regulatory strategies for new products, ensuring adherence to local regulations from the early stages of development. Seniority Level Entry level Employment Type Full‑time Job Function Legal Retail #J-18808-Ljbffr
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Regulatory Affairs Pharmacist
3 weeks ago
Caloocan, Philippines Dempsey Resource Management Full timeRegulatory Affairs Pharmacist ( Manager / Associate ) Join to apply for the Regulatory Affairs Pharmacist ( Manager / Associate ) role at Dempsey Resource Management Responsibilities Register cosmetics, drugs, food supplements, medical devices, and household hazardous products with the FDA. Prepare for initial and renewal of LTO licenses and coordinate with...
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Regulatory Affairs Pharmacist
3 weeks ago
Caloocan, Philippines Dempsey Resource Management Full timeRegulatory Affairs Pharmacist (cosmetic and beauty products) Join to apply for the Regulatory Affairs Pharmacist (cosmetic and beauty products) role at Dempsey Resource Management The Regulatory Affairs Pharmacist ensures our company's FDA compliance with all relevant regulations across our cosmetics, drugs, food supplements, medical device and household...
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Regulatory Affairs Pharmacist
4 weeks ago
Caloocan, Philippines Lifestrong Marketing Inc. Full timeRegulatory Affairs Pharmacist (Cosmetic and Beauty Products) Caloocan, National Capital Region, Philippines Ensures the 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...
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Regulatory Affairs
1 week ago
Caloocan City, National Capital Region, Philippines Lifestrong Marketing Inc. Full time $30,000 - $60,000 per year· Assigned LTO: Lifestrong Cosmetic and DrugDOCUMENTATIONEnsures that all pertinent documents are available for FDA inspectionCompile and maintain complete technical data of each product.Develop and maintain Standard Operating Procedures (SOPs)Direct and monitor the preparation and real-time submissions of License to Operate, Cosmetic Notifications, CPRs...
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Regulatory Affairs
3 days ago
Caloocan City, National Capital Region, Philippines Lifestrong Marketing Inc. Full timeQUALITY 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...
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Regulatory Pharmacist
3 weeks ago
Caloocan, Philippines Lifestrong Marketing Inc. Full timeThe 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...
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Caloocan, Philippines Dempsey Resource Management Full timeRegulatory Affairs Pharmacist Supervisor – 3 yrs Experience Apply for the role at Dempsey Resource Management. Location: Caloocan, Philippines. Requirements (Qualifications) Bachelor's degree in Pharmacy or related field. Experience in regulatory affairs within the pharmaceutical industry. Strong knowledge of FDA, EMA, and other regulatory bodies....
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Regulatory Pharmacist
3 weeks ago
Caloocan, Philippines Dempsey Resource Management Inc. Full timeRegulatory Affairs Pharmacist ensures our company's FDA compliance with all relevant regulations across our cosmetics, drugs, food supplements, medical device and household hazardous products. You will play a key role in developing regulatory strategies, inspection compliance, FDA correspondence and registration of our products. Knowledgeable in FDA rules...
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Regulatory Affairs
7 days ago
Caloocan, Philippines Lifestrong Marketing Inc. Full time· Assigned LTO: Lifestrong Cosmetic and Drug DOCUMENTATION Ensures that all pertinent documents are available for FDA inspection Compile and maintain complete technical data of each product. Develop and maintain Standard Operating Procedures (SOPs) Direct and monitor the preparation and real-time submissions of License to Operate, Cosmetic Notifications,...
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Regulatory Affairs Pharmacist Supervisor
3 weeks ago
Caloocan, Philippines Dempsey Resource Management Inc. Full timeCompliance and Control Register our cosmetics, drugs, food supplements, medical device and household hazardous product at FDA. Prepare for initial or renewal of LTO licenses and coordinate with the FDA inspector Handle and resolve Notice of Compliance from FDA Maintain current knowledge of relevant regulations in Cosmetics and keeping up to date with the...
