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.