Director, CMC Regulatory

Regulatory Affairs


Description

Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines.  Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease.  By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them. 

 

Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient. 

 

Reporting to the Chief Regulatory Officer, the Director, CMC Regulatory will work closely with Pharmaceutical Sciences, GMP Quality Assurance, and cross-functional project teams, to develop and operationalize CMC regulatory strategies in support of Epizyme’s business objectives.

 

Responsibilities

  • Provide strategic CMC regulatory leadership in support of Epizyme’s portfolio of early- and late-stage development programs, as well as future marketed products.
  • Interact effectively with cross-functional stakeholders, including colleagues in Regulatory, Pharmaceutical Sciences, and GMP QA, as well as external development and manufacturing partners.
  • Lead and manage the timely preparation of high-quality CMC documents and submissions, including INDs/CTAs/IMPDs, NDAs/MAAs, amendments, supplements, responses to information requests, and briefing documents for regulatory agency interactions.
  • Ensure that CMC submissions are complete and meet applicable regulatory requirements.
  • Work with Pharmaceutical Sciences, to prepare for and conduct CMC-related meetings with regulatory agencies.
  • Lead CMC regulatory intelligence activities, monitoring guidelines and trends, interpreting CMC regulations and guidance documents, and providing regulatory advice to in-house CMC and project teams.
  • Work with Pharmaceutical Sciences and GMP to assess proposed manufacturing changes, providing strategic regulatory guidance and define reporting requirements.
  • Conduct risk assessments and develop mitigation strategies for CMC regulatory matters.
  • Support on-site regulatory inspections as a Subject Matter Expert (SME).
  • Provide input on SOP development.

Education & Requirements

  • Bachelor’s degree in a scientific or engineering discipline; advanced degree (MS or Ph.D.) preferred.
  • 10+ years of relevant industry experience, with a combination of experience in small molecule CMC development, manufacturing, and/or CMC regulatory with 5+ years in a Regulatory CMC role.
  • Successful track record in CMC submissions to regulatory agencies and meetings.
  • Strong knowledge of current Good Manufacturing Practices (cGMPs), as well as drug development guidelines and regulations (ICH, FDA, and EMA).
  • Ability to lead, motivate, and engage others to ensure successful delivery of projects.
  • Strong interpersonal, project management, and organizational skills with experience in issue resolution and closure.
  • Superb technical-regulatory writing and oral communication skills, with the ability to shape, frame, and present to diverse audiences. Experience in interacting with regulatory authorities required.
  • Ability to analyze complex issues and to develop proactive recommendations that translate strategy into action.
  • Proficiency in Microsoft Office, Adobe Acrobat, SharePoint, and electronic publishing.
  • Occasional travel may be required (approximately 5 % of time).
  • Clear alignment with Epizyme’s Core Values: Collaboration, Disciplined, Innovative, Openness, Patient-Focused, and Resilient.

Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.