Director, Regulatory Affairs
The Director of Regulatory Affairs at MapLight Therapeutics will lead global regulatory strategies for development-stage neuroscience programs. This role involves serving as the regulatory lead on cross-functional teams, ensuring the advancement of product candidates from early development through approval. The position is integral to MapLight's mission of developing targeted therapies for central nervous system disorders.
Key responsibilities include collaborating with the Senior Director of Regulatory Affairs to develop innovative regulatory strategies, providing guidance on clinical development plans, and overseeing the preparation and submission of regulatory documents such as INDs, CTAs, and orphan drug applications. The director will also represent MapLight in interactions with regulatory agencies, monitor changes in the regulatory landscape, and collaborate with external partners to advance development programs.
Candidates should possess an advanced degree in life sciences or a related field, with a minimum of 10 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, focusing on clinical-stage products. Experience in regulatory strategy for neuroscience or CNS therapeutics is highly preferred. The role requires a strong understanding of global regulatory frameworks, demonstrated success in leading regulatory submissions, and excellent communication skills. The ability to work independently in a fast-paced environment is essential.
Compensation for this role ranges from $220,000 to $240,000 annually, with additional benefits including an annual bonus opportunity, stock options, 401(k) plan with match, flexible paid time off, and parental leave. Medical, dental, vision, life, and disability insurance are also provided.
MapLight Therapeutics fosters a collaborative and innovative company culture, emphasizing the development of breakthrough therapies for serious CNS disorders. Employees have opportunities for professional growth and the chance to contribute to pioneering treatments that address significant unmet medical needs.