Join Today: Director, Regulatory CMC
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. Â Â 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 ProcessReady to join us? The first step is easy. Click apply now and we'll be in touch soon!
Apply Now
 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 ProcessReady to join us? The first step is easy. Click apply now and we'll be in touch soon!
Apply Now