Manager, Regulatory Affairs- CMC
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.
The Manager, Regulatory Affairs–CMC, provides regulatory expertise for new product development submission activities and post market for existing products. Responsibilities include implementing global regulatory plans, assessing regulation changes and completion of regulatory deliverables. More specifically, the Manager, Regulatory Affairs Associate – CMC will prepare all of Chemistry, Manufacturing, and Controls (CMC) documentation for submission (e.g., Module 3, Module 2.3, IMPD, and related amendments).
Main Job Duties/Responsibilities
- Author, review and approve CMC documentation for submission (IND, CTA/IMPD, NDA, Annual Reports, Supplements, Amendments and Health Authority Meeting Packages)
- Represent Regulatory CMC in cross-functional project/team meetings (both internal and external)
- Provide regulatory strategies as it pertains to CMC and impact on other disciplines
- Coach and train colleagues with respect to regulatory CMC regulations and best practices
- Review and approve change control changes and track applicable submissions as per regulatory assessments
- Review and approve clinical product labeling for submission to health authorities
- Collect and confirm regulatory documentation required for QP release of IMPs to clinical sites
- Coordinate with external publishing vendor for on-time delivery of high-quality regulatory submissions to regulatory agencies; ensure CMC documentation is prepared according to publishing guidelines
- Develop/improve/implement processes and procedures
- Maintain and update applicable Regulatory CMC databases
- Lead Regulatory CMC intelligence gathering activities
- Perform other duties as assigned
Education & Requirements
- Bachelor's degree in science, math, healthcare, or engineering discipline
- At least 5 years’ experience in Regulatory CMC
- Expert experience authoring/reviewing/approving CMC documentation for regulatory submissions
- Strong written and oral communication skills
- Strong problem solving skills, ability to work with multidisciplinary teams to execute regulatory strategies
- Experience with project management and adherence to project timelines
- Work well under pressure in a dynamic environment
- Ability to multi-task effectively in a 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 help develop and implement process improvements and best practices.
- Knowledge of EDMS (i.e., Veeva RIM)
- Expert knowledge of FDA, ICH and global regulations pertaining to CMC
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.