Regulatory Affairs Specialist

Qualifications

• Candidates should possess strong skills in Regulatory Documentation and Regulatory Submissions to prepare, organize, and file accurate regulatory records.
• Candidates should possess solid knowledge of Regulatory Compliance and Regulatory Requirements to ensure products, services, and processes meet relevant standards and laws.
• Candidates should possess expertise in Regulatory Affairs to coordinate regulatory activities and communicate effectively with regulatory bodies and internal teams.
• Relevant experience in compliance, quality assurance, or legal support within regulated industries (e.g., healthcare, pharmaceuticals, manufacturing, financial services) is highly beneficial.
• Bachelor's degree in a related field such as Regulatory Affairs, Life Sciences, Pharmacy, Engineering, Law, or Business, or equivalent practical experience.
• Strong analytical, documentation, and organizational skills, with attention to detail and the ability to manage multiple deadlines.
• Effective verbal and written communication skills, and the ability to work collaboratively with diverse teams on-site.
• Familiarity with local Philippine regulations and, ideally, international regulatory frameworks (e.g., FDA, EMA, ISO standards) is a plus.