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!