ABOUT THE COMPANY
Our company is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. They specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
Oversees and drives the development and submission of regulatory filings. Manages day-to-day activities related to organization and submission of regulatory documents directly to the Food and Drug Administration (FDA). The Regulatory Senior Manager handles regulatory development and post-approval/regulatory compliance for assigned products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for these products. May perform due diligence efforts on new product opportunities.
• Provides strong leadership in managing regulatory specialists and associates in the preparation, compilation, and submission of high quality submissions (originals, amendments, supplements, and annual reports) for ANDAs, NDAs, control documents, etc. to FDA authorities.
• Participates in the development of regulatory strategy and implementation plans, and ensures that these plans are executed and satisfy regulatory requirements.
• Review and evaluate scientific data and reports required for regulatory submissions for consistency to relevant FDA/ICH CMC guidelines.
• Evaluate change controls and provide accurate regulatory filing assessments in accordance to guidance documents.
• Interact with Research & Development, Quality Assurance/Quality Control (QA/QC), and Production for gathering data and documentation for submissions.
• Ensure regulatory compliance with pre-and post-approval filing and reporting requirements.
• Manage specialist/associates career development and performance.
• Develop a product regulatory timeline aligned to the business unit's product development, with key regulatory milestone, and activities for agency filing
• Coordinate with the Labeling Lead for the development/maintenance of product labels
• Ensure labeling content and product documentation is developed in accordance with regulatory requirements