JOB SUMMARY: The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre- and post- submission. This role is critical in ensuring that products meet all regulatory requirements and meet the regulatory standards of FDAs Office of Generic Drugs. The ideal candidate will have a deep understanding of regulatory affairs related to generic drug development and dossier submission, excellent leadership skills, and a proven track record of successful regulatory submissions and interactions with regulatory agencies. KEY RESPONSIBILITIES: Regulatory Strategy and Compliance: Develop and implement reg