Principal, Regulatory Affairs - Drugs & Biologics
Company overview Panacea is an AI-native regulatory consultancy helping life sciences companies bring therapies to patients faster. We combine a team of expert FDA consultants with experienced AI engineers to accelerate client submissions across all FDA pathways using a specialized in-house AI platform. Panacea leads the intersection between AI and life sciences, and is backed by the world’s leading investors and entrepreneurs including Y Combinator and Emergence Capital. The role You will serve as a senior in-house regulatory expert, helping shape Panacea’s regulatory practices. You will lead regulatory reviews, author and evaluate submissions, conduct gap analyses, and assess the scientific and regulatory adequacy of evidence supporting drug and biologic development programs. Working closely with our AI engineers, scientific researchers, and external regulatory consultants, you will help translate expert regulatory judgment into AI-driven workflows, and establish quality standards. What we’re looking for Minimum of 5-10+ years of experience reviewing drug or biologic applications at FDA CDER or CBER, ideally as a senior reviewer, lead reviewer, or team leader. Direct experience authoring IND submissions and assessing the adequacy of evidence supporting clinical development. Excellent scientific writing, critical appraisal, and attention to detail. Deep expertise in at least one relevant discipline. A willingness to personally inspect data, review documents, and resolve difficult scientific questions. An MD, PhD, PharmD, or other relevant advanced qualification. Ability to work independently, within a multidisciplinary team, and with external partners, consultants, and vendors. Ability to perform in a fast-paced and continually evolving business environment. Why join Work at the intersection of frontier AI and life sciences. Help build AI systems that accelerate drug development. Collaborate with world-class AI engineers and researchers. Work directly with the founding team Perks & benefits Fully remote. Medical, dental, and vision coverage. Flexible PTO and paid holidays. Retirement programs. Wellness and work-from-home stipends.
Compensation
Base pay: $240,000-280,000 Sign-on bonus: $5,000 - $10,000 Variable stock options & profit sharing Annual performance bonus The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions.