Regulatory Affairs Associate

Position Overview The Regulatory Affairs Associate will support Genohope's regulatory compliance activities, with a primary focus on pharmaceutical wholesale distribution regulations and licensing requirements across all 50 U.S. states . The ideal candidate should have a foundational understanding of U.S. pharmaceutical regulations and the ability to research, interpret, and apply federal and state regulatory requirements. In addition to regulatory responsibilities, this position will provide operational support, including warehouse coordination, inventory documentation, and other administrative activities as needed. As part of a growing team, the successful candidate should be adaptable, organized, and comfortable working across multiple functions. Key Responsibilities 1. Regulatory Affairs & State Licensing Research, interpret, and maintain knowledge of pharmaceutical wholesale distribution and third-party logistics (3PL) regulations across all 50 U.S. states. Assist with applications, renewals, amendments, and maintenance of state pharmaceutical wholesale distributor and applicable 3PL licenses. Monitor changes in federal and state regulations that may affect the company's pharmaceutical distribution activities. Maintain an organized database of state-specific licensing requirements, application procedures, renewal deadlines, and compliance obligations. Prepare and organize regulatory submissions, supporting documentation, and correspondence with state regulatory agencies. Support compliance with applicable FDA regulations, the Drug Supply Chain Security Act (DSCSA), and relevant state pharmaceutical distribution requirements. Assist management in evaluating regulatory requirements when expanding distribution activities into additional states. Coordinate with external regulatory consultants and licensing service providers when necessary. 2. Regulatory Documentation & Compliance Support Maintain accurate and organized regulatory records, licenses, permits, and compliance documentation. Assist in developing, reviewing, updating, and maintaining Standard Operating Procedures (SOPs). Support regulatory inspections, audits, and requests for documentation. Coordinate with internal teams to ensure operational procedures align with applicable regulatory requirements. Assist in maintaining supplier qualification records, product documentation, and related compliance files. Identify potential compliance concerns and communicate findings to management. 3. Operations & Warehouse Support As part of a growing company, the Regulatory Affairs Associate will also assist with general operations when needed. Responsibilities may include: Assist with daily warehouse operations, including receiving, inventory management, order preparation, and shipping coordination. Support documentation and recordkeeping for incoming and outgoing pharmaceutical materials. Assist in verifying product information, shipment documentation, and inventory records. Support general administrative tasks, vendor coordination, and operational projects as assigned. Qualifications Required Qualifications Bachelor's degree in Pharmaceutical Sciences, Biology, Chemistry, Life Sciences, Regulatory Affairs, Business Administration, or a related field, or equivalent relevant experience. Foundational knowledge of U.S. pharmaceutical regulations, regulatory compliance, or pharmaceutical distribution requirements. Ability to research, understand, and interpret regulatory information from federal and state agencies. Strong organizational skills and attention to detail. Excellent written and verbal communication skills. Proficiency in Microsoft Office applications, including Excel, Word, and Outlook. Ability to manage multiple tasks and maintain accurate documentation. Willingness to support both regulatory affairs and general business operations in a startup environment. Preferred Qualifications 1–2 years of relevant experience in regulatory affairs, pharmaceutical distributi…

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