Director, Regulatory CMC
October 1
Description
• Responsible for developing CMC regulatory strategy for Crinetics’ products • Provide strategic CMC regulatory leadership support for multiple innovative programs • Serve as the primary regulatory representative on project teams • Lead negotiations with regulatory agencies • Oversee proactive interactions with regulators globally • Maintain and be accountable for CMC regulatory timelines • Assess and communicate regulatory requirements
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 with producing CMC sections from early development to pre- and post-approval submissions • Familiarity with eCTD structure and granularity requirements • Considerable experience with development of CMC development, process validation, comparability protocols, amendments, and supplements • Knowledge of both foreign and domestic regulations pertaining to the development, manufacturing and distribution of 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 write clearly at a level appropriate to the audience and the project with careful attention to detail and accuracy • Strong project management skills with ability to manage multiple projects and execute in adherence to timelines • Desire to work in a collaborative team setting
Benefits
• Discretionary annual target bonus • Stock options • ESPP • 401k match • Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown
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