Exec DirectorVP Regulatory Affairs

Erascais 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 cancersmost 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 Chief Regulatory Affairs Officer the Executive Director or VP Regulatory Affairs will lead regulatory strategy for defined disease area and develop and execute global regulatory strategies and submissions from pre-IND through regulatory approval to launch commercialization and product lifecycle management.

Note that this position can be hybrid in San Diego CA or South San Francisco CA or fully remote anywhere in the United States.

Essential Duties and Responsibilities:

• Represent regulatory on program and study teams and in disease area strategy and planning meetings
• Working with the team develop regulatory strategies to ensure development plans are comprehensive and comply with regulatory requirements
• Lead or support preparation and review of regulatory documents (e.g. IND CTA/IMPD DSUR pre-meeting briefing document iPSP/PIP NDA sNDA) including oversight of regulatory submissions to assure technical accuracy and completeness
• Act as Regulatory Affairs representative in business development and due diligence activities
• Review relevant clinical documents for scientific content and regulatory compliance
• Act as primary liaison with the FDA and OUS 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 and/or inspections
• Regulatory oversight of service providers and regulatory consultants
• Lead and support continued development of new systems and processes to improve efficiency for the regulatory department in a growing organization
• Keep current on US and OUS regulations that apply to company products and processes
• Perform all duties in keeping with the Companys core values policies and all applicable regulations

Required Education and Experience:

• Undergraduate degree required; advanced degree preferred
• 10 years of relevant experience in pharma or biotech regulatory affairs required including deep expertise in global regulatory strategy from pre-IND through NDA and post approval
• Proven knowledge and experience in US and EU regulatory affairs required (e.g. IND CTA CTN NDA) and leading formal interactions with health authorities (e.g. pre IND EndofPhase Scientific Advice etc)
• Experience with NDA submission and product approval preferred
• Experience with expedited programs for serious conditions such as FastTrack Breakthrough Therapy Designation PRIME a plus
• Proven knowledge of 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
• Effective interpersonal communication and influencing skills including excellent writing skills
• Experience leading mentoring and developing direct reports
• Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems.
• Strong learning orientation curiosity and commitment to science and patients

The anticipated salary range for this position is $275000 to $355000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry education etcetera. In addition to base salary the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.

Along with our casual collaborative and fun work and the chance to make your mark in our mission to erase cancer Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off Holiday and Sick Leave Medical Dental and Vision Plans Short- and Long-Term Disability Basic and Voluntary Life/AD&D Coverage Flexible Spending Accounts (FSA HSA and Commute) Critical Illness and Accident Coverage Pet Insurance Employee Assistance Program 401(k) Plan with Erasca contribution and the opportunity to participate in an Employee Stock Purchase Program.

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.