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Director or Sr Director, Regulatory Affairs

San Diego, CA or remote

Erasca is a San Diego based biotechnology company focused on discovering and developing precision medicines for the benefit of patients with cancer. We are advancing multiple programs targeting biological drivers of cancer and are pursuing additional pipeline expansion opportunities through academic and biopharmaceutical collaborations. Our programs, currently focused on innovative discovery research, take novel approaches to shutting down certain oncogene drivers of solid tumor malignancies. 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 Head of Regulatory Affairs, the Director or Sr Director of Regulatory Affairs will develop and execute global regulatory strategies and submissions for assigned programs from pre-IND through regulatory approval to launchcommercialization and product lifecycle management.  

Essential Duties and Responsibilities: 

  • Represent regulatory on program and study teams 
  • Working with the team, develop regulatory strategies to ensure (nonclinical, clinical, CMC) development plans are comprehensive and comply with regulatory requirements 
  • Lead or support preparation and review of regulatory documents (e.g., IND, CTA/IMPD, DSURpre-meeting briefing document, iPSP/PIP, NDA), including oversight of regulatory submissions to assure technical accuracy and completeness 
  • Review of relevant clinical documents for scientific content and regulatory compliance 
  • Primary liaison with the FDA and x-US health authorities to facilitate timely review and approval of regulatory submissions, and lead regulatory milestone discussions (e.g., pre-IND, End-of-Phase, pre-NDA meetings, EU Scientific Advice) 
  • Plan and direct regulatory activities through regulatory staff and cross functional teams 
  • Provide regulatory support for company compliance initiatives 
  • Regulatory support and guidance for regulatory audits/ inspections 
  • Regulatory oversight of service providers/regulatory consultants 
  • Lead/support continued development of new systems/processes to improve efficiency for the regulatory department in a growing organization 
  • Keep current on US and x-US regulations that apply to company products and processes 
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations 

Required Education and Experience: 

  • Undergraduate degree required; advanced degree preferred 
  • 8+ years of relevant experience in pharma or biotech regulatory affairs required, including deep expertise in global regulatory strategy from pre-IND through NDA/post approval 
  • Proven knowledge and experience in US/EU regulatory affairs required, including track records of approvals of regulatory applications (e.g., IND, CTA, CTN; NDA preferred) and interactions with health authorities (e.g., pre IND, EndofPhase, Scientific Advice; pre-NDA preferred) 
  • Exposure to companion diagnostic development a plus 
  • Proven experience forging new ground and developing innovative and collaborative regulatory strategies for new products highly desired 
  • Experience with expedited programs for serious conditions such as FastTrack, Breakthrough Therapy Designation, PRIME, Rare Pediatric Disease Designation preferred 
  • Proven knowledge and experience with CTD format and electronic submissions 
  • Proven knowledge and experience of GLP/GMP/GCP: FDA and ICH guidelines 
  • Ability to translate regulatory requirements into practical workable plans 
  • 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 
  • Demonstrated proactive approaches to problem-solving with strong decision-making capability 
  • Effective interpersonal, communication and influencing skills, including excellent 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 

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.

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