Associate Director/Director Labeling and Promotional/Advertisement Regulatory Affairs
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, an oral, 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 exploring development candidates in its novel G9a inhibitor program. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted 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.
This position, reporting to Head of Regulatory Affairs, requires an ability to understand and evaluate all perspectives of promotions and advertising and provide clear regulatory guidance.
Primary responsibilities include:
- Providing expert regulatory evaluation of proposed investigator materials, trial recruitment materials, advertising, promotional, medical communications, advisory board materials, and disease state materials to ensure compliance with FDA regulations, guidance, corporate standards and policies, and business objectives.
- Serving as Regulatory lead on the Legal, Medical and Regulatory Review Committee (LMR) for US and global materials.
- Interfacing with Coordinator of the LMR and assisting Commercial with the planning and prioritization of proposed promotional and disease state materials for reviews through the Veeva PromoMats process, ensuring compliance with Epizyme’s processes and standards.
- Providing oversight to relevant external vendors and consultants.
- Working closely with Legal and Regulatory counterparts to help ensure that global development strategies result in commercially viable labeling, in support of promotional claims.
- Owning label development and revision processes.
- Providing regulatory leadership and guidance to Commercial during the development, review and approval of product labelling and advertising materials.
- Providing effective solutions to mitigate identified regulatory risks.
- Appropriately escalate unresolved regulatory compliance issues.
- Acting as primary liaison with FDA’s Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review.
- Working with Regulatory Operations to ensure required OPDP submission of promotional materials are appropriately filed with the FDA.
- Working with LMR team members to provide input into improvement of systems and/or processes.
- Providing regulatory input on concepts and draft materials.
- Offering regulatory feedback for Company Core Data Sheet (CCDS) and product label development.
- Keeping current with industry and regulatory developments relating to advertising and promotion, including interpretation of FDA enforcement letters, interpretation of new and updated Guidance Documents for Industry, and, as applicable, evaluating related internal policies/best practices and processes.
- Participating in Regulatory Department, Regulatory Subteam, Commercial Functional Team, and other meetings, as needed.
- Participate in training of Medical Science Liaisons (MSLs), and sales and marketing personnel on promotional, labelling and advertising regulations, and product launch materials, and congress booth compliance.
Education & Requirements:
- BA/BS Degree required, preferably in a health/life sciences or related field.
- Minimum of 8 years in Regulatory including ~5 years of experience as a regulatory reviewer of advertising and promotional materials within the pharmaceutical industry. Experience with FDA Subpart H pre-approval submissions strongly preferred.
- Strong knowledge of regulations and their interpretation relevant to prescription drug advertising, promotion and labeling.
- Commercial launch and advisory comment process experience desired.
- Require limited direction to complete standard and non-standard work.
- Must be innovative, driven and effective with a “can do” attitude.
- Must possess excellent interpersonal and communication skills.
- Must have the ability to build and maintain positive relationships with management, peers, and cross functional colleagues.
- Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail required.
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.