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

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