Director, Regulatory CMC
Posted 2025-03-14Description:
? 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
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