Director, CMC Regulatory Affairs - 2389
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
Key Responsibilities & Accountabilities:
- Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that management, project team colleagues and partners are informed of current regulation, regulatory guidance and guidelines, and development risks and opportunities that may impact regulatory success for Editas pipeline products.
- Serve as a Regulatory CMC Lead on relevant cross-functional or functional teams that require experienced interpretation of applicable FDA/EMA/ICH/WHO/Global regulations to ensure CMC compliance.
- Accountable for CMC regulatory strategy for assigned portfolio programs, including but not limited to developing innovative approaches, problem solving, assessing the probability of regulatory success, and proposing risk mitigation measures.
- Accountable for the management and delivery of all CMC regulatory milestones, such as those related to global investigational drug filings (e.g., IND/CTA /IMPD /GMO), registrational filings (e.g., BLA, NDS, MAA), and responses to health authority questions/requests.
- Provide regulatory impact assessment on proposed CMC changes.
- Responsible for working with the CMC/technical organization to define CMC strategy and/or content requirements (data, analysis, and documentation) for regulatory submissions and reviewing content for conformance with established requirements. Lead CMC related interactions with the health authorities including but not limited to planning for the related activities, managing preparation of meeting requests and briefing documents and contingency plan, preparing responses to preliminary comments.
- Represent Regulatory Affairs on CMC due diligence teams as required.
Knowledge, Skills & Capabilities:
- A broad understanding of the drug discovery and development process is required.
- This position requires a thorough knowledge of CMC related regulatory guidance and guidelines, GMP requirements, and an understanding of clinical ICH Good Clinical Practice Guidelines.
- Proven experience in critically reviewing detailed CMC-related scientific data, analyses, information, study reports and documents, and providing assessment of technical arguments and conclusions based on the data and analyses.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and explain complex information in a concise and clear manner.
- Demonstrated track record for successful interactions with FDA and other global health authorities on CMC topics. Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
- Skilled in planning, organizing, prioritizing, and leading assigned regulatory activities in an efficient and high-quality manner.
- Proficient in Microsoft Office.
Education & Relevant Work Experience:
- Bachelor’s degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 8+ years’ experience in drug development/regulatory affairs and a minimum 5+ years in CMC regulatory affairs.
- Experience with both US FDA and EMA with drugs and/or biologics is required.
- Prior BLA, sBLA, NDA, sNDA or MAA experience is preferred.
- Prior IND, CTA and IMPD experience is required.
- Experience with the regulation of biologics is essential; experience with gene editing and/or cell and gene therapy is preferred.
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.