Associate/Senior Associate, Regulatory Submission Management
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, discipline, innovation, openness, patient-focused and resilience.
Reporting to the Manager, Regulatory Affairs Operations, the Associate/Senior Associate Regulatory Submission Management is responsible for working with Regulatory Leads to support both day-to-day and major submission activities.
- Support Global Regulatory Leads in routine submission operations including: central regulatory calendar maintenance, gathering documents, uploading content to Veeva RIM, organizing and maintaining documents/data in Veeva RIM, regulatory intelligence gathering and dissemination
- Perform day-to-day regulatory project management and operational activities for major submissions including: tracking submission deliverables to maintain target submission dates, commitment/query tracking, status reporting, risk identification, scheduling/leading meetings, operational communications, and developing/reporting metrics.
- Ensure documents for regulatory submission are compliant with company specifications and submission-ready; provide light document formatting support for the Regulatory team.
- Performs submission QC/review for routine submissions and in a supporting role for major submissions to ensure that submissions are correct, complete, and fulfill all regulatory and Epizyme requirements.
- Prepare global submission packages, related correspondence, and metadata for maintenance of the Veeva RIM archive.
- Create and maintain submission plans (table of contents, timelines, responsibilities) for major submissions by working closely with Global Regulatory Leads, Core Team Program Leads, and cross-functional teams. Major submissions may include investigational new drug applications (INDs), clinical trial applications (CTAs), new drug applications (NDA/MAA), major amendments, and meeting information packages.
- Contribute to and/or project manage regulatory initiatives such as SOP development, business process improvements, etc.
Education & Requirements:
- Bachelor’s degree required, preferably with a science background and/or Regulatory Affairs
- At least 2 years of industry experience preferred (or education in Regulatory Affairs)
- Highly adaptable, coachable, and fast learner
- Strong communication and interpersonal skills, including presentation skills
- Exhibit strong attention to detail and organization
- Multi-tasking abilities to support concurrent projects
- Able to successfully manage and prioritize complex projects to deadlines with relative independence
- Experience in project management preferred
- Strong computer skills, especially with MS Word (required), MS Excel, Adobe Acrobat
- Experience with Accenture Starting Point preferred
- Prior Veeva Vault experience preferred
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.