Director, Regulatory Affairs

Are you a seasoned Regulatory Affairs professional ready to make a significant impact on human health? We are seeking a strategic and driven **Director of Regulatory Affairs** to join a pioneering research and development company focused on extending healthy lifespan. This is an exceptional opportunity to play a pivotal role in developing and implementing innovative regulatory strategies for groundbreaking programs. You will collaborate with cross-functional teams and external partners, driving regulatory success from IND-enabling studies through clinical proof-of-concept and beyond. **Your Impact:** - Develop and execute global regulatory strategies for assigned programs, including first-in-class therapies and programs with external partnerships. - Lead interactions with global health authorities, preparing briefing packages and ensuring clear communication. - Collaborate with executive leadership to define regulatory strategies aligned with the company's mission. - Oversee the preparation and submission of regulatory applications, ensuring accuracy and timeliness. - Develop effective CMC regulatory strategies in collaboration with Technical Operations. - Provide strategic regulatory input to development teams, protocols, reports, and other critical documents. - Stay ahead of global regulatory changes, communicating updates and developing proactive strategies. - Collaborate with cross-functional teams and external consultants. - **What You Bring:** - Masters degree in a life science discipline (PhD preferred). - Minimum of 10 years of regulatory affairs experience in industry, academia, or clinical research, with experience in rare disease development and/or novel endpoints. - Proven track record of developing regulatory submissions, including experience with major approvals (NDA, BLA, MAA, etc.). - Strong knowledge of global regulations (FDA, EMA, etc.). - Experience with mechanisms to expedite agency interactions. - Advanced skills in creating and assessing regulatory proposals and leading health authority interactions. - Excellent communication and influencing skills. - Self-motivated, strategic thinker with strong problem-solving skills. - Exceptional organizational and prioritization skills. - Ability to thrive in a fast-paced, collaborative, start-up environment. - Must be willing to work onsite at least four days per week.