Senior Associate, Regulatory Affairs- Advertising, Promotion, and Labeling
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.
This position requires an understanding of basic labeling, advertising and promotional concepts related to commercial communications about marketed products. This position will be responsible for serving as a strategic business partner and liaison across functional stakeholders (e.g., Commercial, Regulatory, Legal, and Medical.) This includes working cross-functionally to manage the end-to-end review process for Epizyme's advertising and promotional review process and eCTD/OPDP submission of finalized materials.
Primary responsibilities include:
- Perform coordination and preparation of Subpart H packages for submission to OPDP.
- Prepare and ensure timely and accurate submission of promotional materials to OPDP on Form 2253.
- Working with Regulatory Operations to ensure required OPDP submission of promotional materials are appropriately filed with the FDA.
- Assist with review and approval of advertising and promotional materials to ensure accuracy based on internal policies and FDA Regulations.
- With supervision, attends labeling committee meetings and provides labeling support and guidance to internal and external customers.
- Assist with the accurate and timely preparation of labeling components: package insert, medication guide, container labeling, etc.
- Reviews labeling change control requests for completeness and accuracy. Assesses the impact of the changes as they relate to approved NDAs and communicates the impact to his/her manager.
- Manage Drug Listing activities and the preparation, review and submission of SPL to the FDA.
- 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.
- Participating in Regulatory Department, Regulatory Subteam, Commercial Functional Team, and other meetings, as needed.
- Perform other duties as assigned.
Education & Requirement
- Bachelor's Degree
- Experience in working in a Regulatory Affairs function
- Effective verbal and written communication skills.
- Experience with solving problems and concerns.
- Experience with project management and adherence to time schedules.
- Work well under pressure in a dynamic environment.
- Ability to multi-task effectively in fast-paced environment
- Highly organized, detail oriented, and efficient.
- Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism.
- Proactively seeks to develop and become well-versed within in the regulatory landscape.
- Some travel may be required.
- Bachelor's degree in science, math, healthcare, or engineering discipline.
- Knowledge of EDMS, especially Veeva RIM.
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.