Executive Director - Regulatory Affairs

February 21

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Iambic Therapeutics

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Iambic Therapeutics is a pioneering biotechnology company that leverages advanced AI algorithms for drug discovery. Their innovative, high-throughput experimental platform aims to address unmet patient needs by optimizing molecules for various therapeutic targets. The company's AI-driven approach allows it to rapidly explore chemical spaces, revealing novel drug mechanisms and delivering high-quality leads at an accelerated pace compared to traditional methods.

machine learning • artificial intelligence • drug discovery • catalysis • materials

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🤖 Artificial Intelligence

🔥 Funding within the last year

💰 Series B on 2024-04

📋 Description

• Lead all aspects of regulatory affairs, including growing a high-performing regulatory team to support the development and approval of multiple pipeline assets. • Develop and implement regulatory strategies for drug development that align with business objectives and timelines. • Oversee the preparation and submission of regulatory documents including INDs, CTAs, BLAs, and NDAs to the FDA and other regulatory authorities. • Serve as the primary point of contact for regulatory agencies and facilitate communication between the company and regulatory bodies. • Provide expert regulatory guidance to cross-functional teams, including clinical development, CMC, and quality assurance. • Monitor and interpret FDA regulations, guidelines, and industry standards; ensure company practices are compliant with these requirements. • Communicate to leadership timely updates on changes to regulatory requirements, or other issues that may impact product development. • Stay informed of the evolving landscape of oncology regulations and lead initiatives to adapt company strategy accordingly.

🎯 Requirements

• Bachelor’s degree in a relevant scientific discipline; advanced degree (PhD, MD, or equivalent) preferred. • Minimum of 10 years of experience in regulatory affairs, with specific experience in oncology drug development. • Proven track record of leading successful regulatory submissions and interactions with regulatory agencies. • Deep understanding of FDA regulations, and international regulatory requirements (EMA, ICH, etc.). • Strong leadership skills with experience managing cross-functional teams. • Excellent communication, negotiation, and interpersonal skills. • Ability to work in a fast-paced and dynamic environment, demonstrating flexibility and adaptability.

🏖️ Benefits

• Industry leading competitive pay • Company paid healthcare • Flexible spending accounts • Voluntary life Insurance • 401K matching • Uncapped vacation