The Associate Director of Regulatory Affairs will be responsible for leading the development and delivery of global regulatory strategies for assigned programs in alignment and compliance with local and regional requirements as well as with company policies. Reporting to the VP of Regulatory Affairs, the Associate Director will independently lead project work for assigned programs and develop high quality submissions for global clinical trials and registrations. Programs may be complex with multiple indications, combination therapies, companion diagnostics, and working with external development partners (CROs and Alliance Partners).
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 thoughtful & accurate comments during document (e.g., IB, protocols/amendments, ICFs, study reports, etc.) review, mindful of regulatory/ICH guidance/requirements pertaining to document content
Education & Requirements
Bachelor's degree in life sciences required; advanced degree preferred
Minimum of 8 years in Regulatory Affairs with a B.S./B.A., or 8 years with M.S., or 5 years with Ph.D./M.D.
Established knowledge of drug development, with small molecule experience preferred
Regulatory experience in Oncology preferred
Excellent knowledge of FDA and ICH regulations and guidelines a must, with experience as FDA liaison
Knowledge of EU and Health Canada 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
Internal Number: 1408
About Epizyme Inc.
Epizyme, Inc. is a clinical-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.