Regulatory Affairs Pharmacist

1 month ago


Dasmariñas, Philippines Sydenham Laboratories Inc Full time

What you'll be doingStaying up-to-date with changing regulatory requirements and guidelines in the pharmaceutical and medical device industriesPreparing and submitting regulatory documentation such as marketing authorisation applications, clinical trial applications, and post-approval variationsLiaising with regulatory authorities to address queries and secure approvals for our productsProviding regulatory guidance and support to the research and development, manufacturing, and quality assurance teamsMaintaining comprehensive records and databases to track the regulatory status of our product portfolioIdentifying and mitigating potential regulatory risks to the businessContributing to the development and implementation of regulatory strategies aligned with the company's commercial objectivesWhat we're looking forPharmacy degree and valid registration as a pharmacistMinimum 5 years' experience in a regulatory affairs role within the pharmaceutical or medical device industryIn-depth knowledge of regulatory requirements and guidelines in the Philippines and other key marketsExcellent written and verbal communication skills, with the ability to liaise effectively with both internal and external stakeholdersStrong attention to detail and problem-solving skillsAbility to work independently and as part of a cross-functional teamProficiency in using regulatory information management systems and databases



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