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).

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 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