Associate Director/Director, Regulatory Operations

Company: Foghorn Therapeutics
Location: Cambridge
Posted on: February 25, 2021

Job Description:

Associate Director/Director, Regulatory Operations Foghorn Therapeutics is pioneering the discovery and development of a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system, an untapped opportunity for therapeutic intervention. Our proprietary Gene Traffic Control-- platform gives us an integrated, mechanistic understanding of how the various components of the chromatin regulatory system interact, allowing us to identify, validate and potentially drug targets within the system.---The Company, currently in pre-clinical stage, is advancing over 10 small molecule and protein degrader programs across a wide range of cancers.-- -- Foghorn--was founded in 2016 by--Cigall--Kadoch, Ph.D., Gerald Crabtree, M.D., and Doug Cole, M.D., of Flagship Pioneering. Learn more about Foghorn at--- www.foghorntx.com . -- About the Chromatin Regulatory System -- The chromatin regulatory system regulates gene expression by directing the movement of molecules that turn genes on and off. Disease dependencies associated with the chromatin regulatory system are estimated to impact over 2.5 million cancer patients across the United States,--Europe--and Japan. This system is further implicated in neurological, autoimmune, and other serious diseases. -- Job Summary Foghorn Therapeutics is seeking a highly experienced and trusted leader for the role of Associate Director/Director, Regulatory Operations. This Associate Director/Director will build the regulatory operations eDMS infrastructure and define processes for the preparation of compliant regulatory submissions to global health authorities. They will work collaboratively with internal cross-functional team members and external vendors and oversee submissions across the Foghorn growing portfolio. A successful candidate will be detail-oriented and direction-setting. Specific Responsibilities

• Oversee and plan the compilation of regulatory submissions to global health authorities
• Prepare compliant submission-ready documents and coordinate eCTD submission activities with external publishing vendor
• Create and manage tracking systems for regulatory submissions and correspondence, including health authority questions and sponsor commitments
• Maintain submission authoring templates. Provide end-user support and training
• Construct strategies, implement and maintain RIM and IDMP systems
• Act as primary contact and super user for regulatory operations software and systems; Contribute technical expertise for configuration and customization
• Develop Standard Operating Procedures and best practices for preparing, publishing, and archiving regulatory submissions. Qualifications
  • 8+ (Associate Director) or 10+ years (Director) of Regulatory Operations experience in a biotech/pharmaceutical industry
  • A minimum of a bachelor's degree in life-sciences or industry related discipline
  • Advanced knowledge of regulatory electronic document management systems (eDMS)
  • Proficient in Microsoft Office applications and Adobe Acrobat. Preferred experience with StartingPoint templates
  • Knowledge of current regulations and guidelines related to global regulatory dossier submissions standards
  • Demonstrated ability to lead a project, operate with a sense of urgency and oversee complex eCTD submissions
  • Authentic and clear communication skills; collaborative and respectful team member

Keywords: Foghorn Therapeutics, Cambridge , Associate Director/Director, Regulatory Operations, Executive , Cambridge, Massachusetts