Sr Manager/Assoc Director Regulatory Affairs

March 29

Erasca, Inc.

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Our mission at Erasca is embedded in our name: To erase cancer.

51 - 200

💰 $100M Post-IPO Equity on 2022-12

Description

• Lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials • Represent regulatory on study and program teams throughout study conduct and product development • Prepare and/or review regulatory documents required for product development • Serve as primary contact with the FDA and lead global regulatory submissions • Provide oversight of regulatory submissions, assure technical accuracy, compliance, and completeness • Keep current on US and OUS regulations that apply to company products and processes • Support other global submission activities as appropriate

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 • Strong organizational skills, ability to prioritize tasks with excellent attention to detail • Ability to build strong relationships with various stakeholders • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment • Effective interpersonal and communication skills, collaborative team player with a can-do attitude

Benefits

• Competitive salary • Health insurance coverage • 401(k) retirement plan • Paid time off and holidays • Professional development opportunities