Associate Director, Regulatory Affairs

Regulatory Affairs


Description

Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.

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. 

Key Responsibilities:

  • Develop and implement well-informed global regulatory strategies in a project team environment, with a focus on clinical and nonclinical drug development
  • Represent Epizyme as liaison with the FDA, including telephone calls, e-mail and written submissions for assigned projects; prepare Epizyme team and facilitate the meetings and teleconferences between company and FDA
  • Interact with Regulatory Affairs personnel at partner companies and vendors
  • Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements
  • Significant contribution to development of relevant processes and procedures to support the Regulatory Affairs function activities
  • Ensure compliance with regulatory requirements; familiar with a variety of US and non-US regulatory concepts, requirements and expectations; maintain awareness and communicate with team members regarding changing regulatory requirements
  • Execute simple and complex regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, NDAs, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival)
  • Establish and meet bold timelines for regulatory submissions using expedited development pathways
  • Provide regulatory advice to cross-functional project on the regulatory requirements to support nonclinical/clinical document development (e.g., IB, protocols/amendments, ICFs, study reports, etc.) review, mindful of regulatory/ICH guidance/requirements pertaining to document content
  • Maintain current knowledge of FDA as well as other Health Authorities (such as Health Canada, EMA, APAC) requirements for regulatory submissions and ensure that all submissions comply with the requirements
  • Identify potential risks to submission plans and propose risk mitigation strategies
  • Be proficient with utilizing eDMS, Veeva Vault for regulatory submissions
  • Track regulatory activity and commitments

 

Education & Requirements:

  • Bachelor's degree in life sciences required; advanced degree preferred
  • Minimum of 7 years in Regulatory Affairs with M.S., or 5 years with Ph.D./M.D.
  • Established knowledge of drug development, with small molecule experience preferred
  • Excellent knowledge of FDA and ICH regulations and guidelines a must, with experience as FDA liaison
  • Knowledge of EU, Health Canada and APAC regulations and guidelines desirable
  • Proven track record of effective collaboration with multi-faceted project teams is a must
  • Excellent written and oral communication skills required
  • Excellent interpersonal skills
  • Ability to work independently in a highly dynamic drug development environment
  • Capable of multi-tasking, setting priorities, and meeting timelines
  • Demonstrated ability to shape, frame, and present to diverse audiences is an absolute must
  • Proven evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents use din regulatory planning and submissions
  • Strong project management skills and drive for excellence
  • Experience with electronic submissions in the US and exUS
  • Demonstrated ability to form strong working relationships cross-functionally
  • Experience in rare disease or oncology preferred

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