Director, Regulatory CMC

Description: • Responsible for developing CMC regulatory strategy for Crinetics’ products • Ensure alignment with Health Authority requirements and product development objectives • Provide strategic regulatory leadership support for multiple innovative programs • Serve as the primary regulatory representative on project teams • Lead negotiations with regulatory agencies to resolve CMC issues • Oversee proactive interactions with regulators for INDs/CTAs, marketing applications, and maintenance • Maintain and be accountable for CMC regulatory timelines • Assess and communicate regulatory requirements for development activities • Provide regulatory support for relevant quality systems • Support interactions with regulatory agencies during inspections • Other duties as assigned Requirements: • Advanced relevant life sciences degree, e.g., MS, PhD • At least 10 years regulatory CMC experience in biotech/pharmaceutical industry • A minimum of 8 years in a supervisory/people manager role •... Experience producing CMC sections from early development to pre- and post-approval submissions • Familiarity with eCTD structure and granularity requirements • Experience with CMC development, process validation, comparability protocols, amendments, and supplements • Knowledge of foreign and domestic regulations for investigational and commercial drugs • Detailed knowledge of GMP, ICH guidelines, and related FDA/EMA guidance regarding CMC submission elements • Experience with electronic document control and management systems • Ability to manage multiple projects and adhere to timelines • Strong regulatory writing skills with clear communication in English • Excellent project management skills Benefits: • Discretionary annual target bonus • Stock options • Employee Stock Purchase Plan (ESPP) • 401k match • Top-notch health insurance plans for employees (and their families), including medical, dental, vision, and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown Apply Job!