Sr Manager Assoc Director Regulatory Affairs at Erasca

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.

The anticipated salary range for this position is $190,000 to $200,000. 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.