Position Title:

Sr. Director, Regulatory Affairs

 

  Reports To:

Head of Regulatory Affairs

Position Summary:

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.

Reporting to the Head of Regulatory Affairs, Senior Director of Regulatory Affairs will develop and execute the global regulatory strategies and submissions for assigned programs from pre-IND through regulatory approval to launch, commercialization and product lifecycle management. This position will also oversee global Regulatory CMC activities for all Erasca’s programs.

Essential Duties & Responsibilities:

·       As the Regulatory Lead for assigned programs:

–        Represent regulatory on program teams

–        Develop regulatory strategies to ensure (nonclinical, clinical, CMC) development plan are comprehensive and comply with regulatory requirements

–        Lead preparation and review of regulatory documents (e.g., IND, CTA/IMPD, annual report, briefing document, iPSP/PIP, NDA), including oversight of regulatory submissions to assure technical accuracy and completeness

–        Review of relevant clinical documents (protocol, consent form, investigator’s brochure, safety report) 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)

·       Oversee Regulatory CMC activities for Erasca’s programs:

–        Provide regulatory guidance to CMC function

–        Develop and implement regulatory CMC strategies, in conjunction with the program’s Regulatory Lead

–        Lead preparation and submission of regulatory CMC-specific documents (module 3 for IND/NDA; IMPD; briefing document)

–        Lead regulatory CMC focused interactions with FDA and x-US health authorities

·       Regulatory oversight of service providers/regulatory consultants

·       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

·       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 Regulatory CMC 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., preIND, EndofPhase, Scientific Advice; pre-NDA preferred)

·       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 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.