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Senior or Executive Director, Regulatory CMC

San Diego, CA or remote

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

Position Summary: 

Reporting to the SVP of Regulatory Affairs, the Senior or Executive Director of Regulatory CMC will drive, manage, and execute the regulatory strategies and activities associated with global drug development. This role requires an experienced drug developer that is self-directed, detailed oriented, and highly motivated. 

Essential Duties and Responsibilities: 

  • Develop regulatory strategies to ensure manufacturing and development plans are comprehensive and comply with regulatory requirements in all relevant regions 
  • Oversee the preparation of regulatory submissions to assure technical accuracy and completeness 
  • Provide regulatory support for new and ongoing company compliance initiatives 
  • Interact with the FDA and OUS regulatory bodies to facilitate timely submission, review, and approval of INDs, CTAs, and marketing authorization applications  
  • Provide regulatory guidance to product teams and leadership  
  • Regulatory member of GMP change control committee 
  • Review of clinical, pre-clinical, and manufacturing documents for scientific content and regulatory compliance 
  • Review and prepare responses to requests from regulatory authorities relating to products 
  • Prepare (and create strategy and timeline for) CMC modules for IND applications, routine reports/updates, IND amendments, and meeting requests with regulatory agencies 
  • Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations

Required Education and Experience: 

  • Undergraduate degree in related field (biology, microbiology, chemistry) required; advanced degree preferred 
  • 10+ years of experience in CMC regulatory affairs required; additional biotech or pharma experience preferred 
  • Proven knowledge and skills in pharmaceutical or biotech regulatory affairs required, including CMC regulatory affairs for products in the US and Europe; experience in additional OUS regions preferred 
  • The ideal candidate will have extensive and diverse experience in regulatory CMC, including interpretation of data, submission of documents to regulatory bodies, and leading formal interactions with regulatory agencies 
  • Proven experience developing innovative and collaborative regulatory strategy for new expedited products highly desired 
  • Experience leading regulatory CMC activities for clinical stage manufacturing required; commercial manufacturing and/or product launch a plus 
  • Proven knowledge and experience with CTD format and electronic submissions 
  • Proven knowledge and experience of GLP/GMP/GCP: FDA and ICH guidelines 
  • Strong organizational skills that reflect the ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail 
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment 
  • Excellent interpersonal, communication and influencing skills, including effective writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems 
  • Strong learning orientation, curiosity, and passion for science and patients

Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.