Job Description
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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