Level up your career with a new role at workwarp as a Director, Regulatory CMC! We are hiring for our Remote location, and the role is available for immediate commencement. This position requires a strong and diverse skillset in relevant areas to drive success. The compensation for this role is a competitive salary, reflecting our commitment to attracting the best.   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 Â... 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!  Simple Application Process Ready to join us? The first step is easy. Click apply now and we'll be in touch soon!