Sr Manager or Assoc Director Regulatory Affairs - Erasca
San Diego, CA
About the Job
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, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials. This role requires an independent, self-directed, and highly motivated clinical regulatory professional.
Position Responsibilities:
- Represent regulatory on study and program teams throughout study conduct and product development.
- Prepare and/or review regulatory documents required for product development (e.g. New IND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA)
- Serve as the primary contact with the FDA, and lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required.
- Provide oversight of regulatory submissions to assure technical accuracy, compliance, and completeness.
- Provide regulatory support for company compliance initiatives, including SOP development, Veeva and documentation initiatives, etc.
- Review relevant clinical documents (protocol, informed consent form, investigator's brochure, and site documentation, and required regulatory forms) for regulatory compliance.
- Keep current on US and OUS regulations that apply to company products and processes.
- May support other global submission activities as appropriate, independently or in collaboration with the Regulatory Affairs Head or Regulatory Affairs program lead
- Perform all duties in keeping with the Company's core values, policies, and all applicable regulations.
Position Requirements:
- Undergraduate degree required; advanced degree preferred.
- 4+ years of experience in pharmaceutical or biotech regulatory affairs including clinical regulatory affairs for oncology products.
- Ability to translate regulatory requirements into practical workable plans.
- Diverse experience with regulatory activities including creation of systems and processes to support efficient and high quality submission of documents to regulatory bodies.
- Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail.
- Ability to build strong relationships with co-workers of various backgrounds and expertise.
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
- Effective interpersonal and communication 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.
Theanticipatedsalaryrangefor this position is$190,000 to $200,000. Thefinalsalaryofferedtoasuccessfulcandidatewillbedependentonseveralfactorsthatmayincludebutarenotlimitedtothetypeandlengthofexperiencewithinthejob,typeandlengthofexperiencewithintheindustry,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.