Regulatory Affairs Specialist
Detail posisi
Kewajiban
• Prepare, review, and submit regulatory documents to health authorities (e.g., FDA, EMA, Health Canada) for product approvals, including INDs, NDAs, PMAs, and 510(k)s.
• Maintain an up-to-date submission calendar to ensure timely filings.
• Monitor changes in regulatory guidelines and assess their impact on the company’s products and processes.
• Ensure that all product labeling, advertising, and promotional materials comply with regulatory requirements.
• Work closely with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure compliance throughout the product lifecycle.
• Provide regulatory guidance and support during product development, clinical trials, and post-market activities.
• Maintain comprehensive records of all regulatory submissions, correspondence, and approvals.
• Prepare and maintain internal documentation and training materials related to regulatory compliance.
• Conduct risk assessments for new products and changes to existing products.
• Provide recommendations for mitigating regulatory risks.
• Stay informed about industry trends, regulatory changes, and best practices.
• Conduct training sessions for internal teams on regulatory compliance requirements.
• Prepare for and participate in regulatory inspections and audits.
• Respond to regulatory inquiries and issues raised by health authorities.
Kualifikasi
• Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s preferred).
• 2-3+ years of experience in regulatory affairs within [specific industry, e.g., agriculture, pharmaceuticals, medical devices, cosmetics].
• Strong understanding of regulatory requirements and processes in relevant markets.
• Excellent written and verbal communication skills, with the ability to convey complex information clearly.
• Strong analytical and problem-solving abilities, with attention to detail.
• Familiarity with regulatory submission software and tools.