Vice President, Regulatory Affairs

Vice President, Regulatory Affairs About the Company Innovative biopharmaceutical company IndustryPharmaceuticals TypePrivately Held About the Role The Company is seeking a Vice President of Regulatory Affairs to lead the strategic development and execution of regulatory plans for innovative neuropsychiatric therapies. The successful candidate will be responsible for guiding the regulatory pathways of these novel treatments, ensuring compliance with all regulatory requirements, and driving the process from conception to market release. This pivotal role involves close collaboration with executive leadership and regulatory teams to shape strategies that align with clinical and business objectives. Key responsibilities include overseeing regulatory submissions to the U.S. FDA and EMA, providing expert guidance on regulatory standards, and fostering a high-performance culture that supports excellence in regulatory affairs. The ideal candidate will have a degree in a life sciences field and at least 20 years of experience in regulatory affairs within the biotech or pharmaceutical industry, with a focus on CNS or psychiatric drug development. A deep understanding of global regulatory frameworks, hands-on experience in end-to-end regulatory strategy execution, and a proven track record in IND, NDA, CTA, and MAA submissions are essential. The role also requires a leader with a visionary and passionate approach, a hands-on leadership style, and a strong background in regulatory compliance, including experience in GxP-regulated environments and knowledge of ICH guidelines. Additional skills such as experience with REMS program implementation and prior regulatory agency experience are highly advantageous. Travel PercentLess than 10% Functions Medical Care/Hospital Administration

Created: 2025-01-30