Director, Regulatory CMC - Shaping the Future of Innovative Therapeutics through Strategic Regulatory Leadership

Join Our Team: Revolutionizing Healthcare through Regulatory Excellence At Crinetics, we're on a mission to transform the lives of patients worldwide by developing innovative therapeutics that address significant unmet medical needs. As a leader in the biotech industry, we're committed to fostering a culture of excellence, collaboration, and continuous learning. We're now seeking an exceptional Director, Regulatory CMC to join our remote team and play a pivotal role in driving the success of our products through strategic regulatory leadership. About Us Crinetics is a biotech company dedicated to developing novel therapeutics that have the potential to revolutionize the treatment of various diseases. Our team is comprised of experienced professionals who share a passion for innovation and a commitment to excellence. We're a company that values collaboration, creativity, and continuous learning, and we're looking for talented individuals to join our team. Job Overview As Director, Regulatory CMC, you will be responsible for developing and implementing the CMC regulatory strategy for our products, ensuring alignment with Health Authority requirements and product development objectives. You will provide strategic regulatory leadership support for multiple innovative programs, serve as the primary regulatory representative on project teams, and lead negotiations with regulatory agencies to resolve CMC issues. Key Responsibilities Develop and implement CMC regulatory strategy for Crinetics' products, ensuring alignment with Health Authority requirements and product development objectives Provide strategic regulatory leadership support for multiple innovative programs, including serving as the primary regulatory representative on project teams Lead negotiations with regulatory agencies to resolve CMC issues and ensure proactive interactions with regulators for INDs/CTAs, marketing applications, and maintenance Oversee and be accountable for CMC regulatory timelines, assessing and communicating regulatory requirements for development activities Provide regulatory support for relevant quality systems, including supporting interactions with regulatory agencies during inspections Manage multiple projects simultaneously, adhering to timelines and demonstrating excellent project management skills Other duties as assigned, with a focus on driving the success of Crinetics' products through regulatory excellence Requirements Essential Qualifications Advanced relevant life sciences degree (MS, PhD or equivalent) At least 10 years of regulatory CMC experience in the biotech/pharmaceutical industry, with a minimum of 8 years in a supervisory/people manager role Experience producing CMC sections from early development to pre- and post-approval submissions, with familiarity with eCTD structure and granularity requirements Knowledge of foreign and domestic regulations for investigational and commercial drugs, including GMP, ICH guidelines, and related FDA/EMA guidance regarding CMC submission elements Experience with electronic document control and management systems, as well as CMC development, process validation, comparability protocols, amendments, and supplements Preferred Qualifications Strong regulatory writing skills with clear communication in English, and excellent project management skills Ability to manage multiple projects simultaneously, adhering to timelines and demonstrating flexibility in a fast-paced environment A track record of successful regulatory interactions and negotiations with regulatory agencies What We Offer At Crinetics, we offer a comprehensive benefits package that reflects our commitment to attracting and retaining top talent. Our benefits include: Discretionary annual target bonus, providing a performance-based incentive to drive success Stock options and Employee Stock Purchase Plan (ESSP), allowing you to share in the company's success and growth 401k match, helping you plan for a secure financial future Top-notch health insurance plans for employees (and their families), including medical, dental, vision, and basic life insurance 20 days of PTO, allowing you to recharge and maintain a healthy work-life balance 10 paid holidays, providing time to relax and enjoy with family and friends Winter company shutdown, giving you a chance to take a break and come back refreshed Career Growth and Development At Crinetics, we're committed to fostering a culture of continuous learning and professional growth. As Director, Regulatory CMC, you'll have opportunities to develop your skills and expertise, take on new challenges, and advance your career. Our team is dedicated to supporting your success, and we provide the resources and guidance you need to thrive. Our Culture At Crinetics, we value collaboration, creativity, and continuous learning. We're a company that encourages innovation, supports diversity, and fosters a culture of excellence. Our team is passionate about developing innovative therapeutics that have the potential to revolutionize the treatment of various diseases, and we're looking for talented individuals to join our mission. Why Join Us? If you're a motivated and experienced regulatory professional looking to drive the success of innovative therapeutics, we want to hear from you. As Director, Regulatory CMC, you'll play a pivotal role in shaping the future of Crinetics' products and contributing to the company's mission. Join our team and be part of a dynamic and growing company that's making a difference in the lives of patients worldwide. Ready to take the next step in your career? Apply now and join our team! Apply for this job