JOB SUMMARY
The Executive Director, Head of Regulatory Affairs will be responsible for overseeing all regulatory affairs activities related to the development of innovative small molecules for the treatment of cancer. This role will involve directing regulatory submissions, ensuring compliance with global regulatory requirements, and actively engaging with regulatory authorities. The ideal candidate will have a strong background in oncology and substantial experience in regulatory processes within the biotech or pharmaceutical industry.
RESPONSIBILITIES
Lead all aspects of regulatory affairs, including growing a high-performing regulatory team to support the development and approval of multiple pipeline assets.
Develop and implement regulatory strategies for drug development that align with business objectives and timelines.
Oversee the preparation and submission of regulatory documents including INDs, CTAs, BLAs, and NDAs to the FDA and other regulatory authorities.
Serve as the primary point of contact for regulatory agencies and facilitate communication between the company and regulatory bodies.
Provide expert regulatory guidance to cross-functional teams, including clinical development, CMC, and quality assurance.
Monitor and interpret FDA regulations, guidelines, and industry standards; ensure company practices are compliant with these requirements.
Communicate to leadership timely updates on changes to regulatory requirements, or other issues that may impact product development.
Stay informed of the evolving landscape of oncology regulations and lead initiatives to adapt company strategy accordingly.
QUALIFICATIONS
Bachelor’s degree in a relevant scientific discipline; advanced degree (PhD, MD, or equivalent) preferred.
Minimum of 10 years of experience in regulatory affairs, with specific experience in oncology drug development.
Proven track record of leading successful regulatory submissions and interactions with regulatory agencies.
Deep understanding of FDA regulations, and international regulatory requirements (EMA, ICH, etc.).
Strong leadership skills with experience managing cross-functional teams.
Excellent communication, negotiation, and interpersonal skills.
Ability to work in a fast-paced and dynamic environment, demonstrating flexibility and adaptability.
ABOUT IAMBIC THERAPEUTICS
Founded in 2019 and headquartered in San Diego, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinical stage with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs. Learn more about the Iambic team, platform, and pipeline at iambic.ai.
MISSION & CORE VALUES
The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life Insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
