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Director, Regulatory Operations

Location: Cambridge
Posted on: March 18, 2023

Job Description:

Director, Regulatory Operations at Relay Therapeutics We are looking for a regulatory operations leader to join our growing regulatory team at Relay Tx. This role will be responsible for regulatory system management and maintenance, and will be working closely with Regulatory Affairs, Medical Writing and external vendors to provide operational oversight and support for the planning, preparation, tracking and timely submission of all eCTD applications (e.g. IND, CTA, NDA etc.). This includes planning of eCTD dossier creation and oversight of publishing activities, submission, tracking, and archiving to achieve submission excellence and ensure regulatory compliance. Your Role:

  • You will work side by side with development partners to define and implement regulatory systems and regulatory standards and procedures for dossier management, publishing, archiving, and submission processes. You will be instrumental in managing and implementing these regulatory systems and processes to ensure achievement of submission excellence and regulatory compliance, and you will provide input in data migration, update/configuration requirements, integration strategies and change management needs for new and existing systems.
  • You will be responsible for creating eCTD submission packages that meet health authority requirements and guidelines from regulatory operational perspective.
  • You will serve as the primary interface between external publishing vendors and oversee the scheduling and coordinated completion of publishing deliverables for regulatory submissions.
  • You will support the organization and maintenance of Health Authority correspondence and regulatory information files to be archived in the regulatory system.
  • You will contribute to the selection of regulatory publishing vendors, eCTD templates, tools and technologies.
  • Monitor and assess business trends, pending regulations and/or guidance documents for potential regulatory operations impact. Your Background:
    • Possesses a solid foundation of regulatory knowledge and drug development experience.
    • A minimum of 10 years of regulatory operation experience in the pharmaceutical industry.
    • Extensive eCTD filing experience with INDs/CTAs and NDAs.
    • Prior experience in building and managing RIM and vendor management of outsourced regulatory operations work.
    • Demonstrated success streamlining document preparation across all internal functions as well as with external vendors, with a focus on opportunities for regulatory process improvement.
    • Knowledge about and experience with Microsoft Office Suite, Adobe Acrobat, RIM and eCTD publishing systems.
    • A collaborative team player and have a "can do" attitude, passionate about the impact of regulatory work to patients' life. #LI-AM1 About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal partsfearlessandrelentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

Keywords: THIRD ROCK VENTURES, LLC, Cambridge , Director, Regulatory Operations, Executive , Cambridge, Massachusetts

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