- As the Director, Regulatory CMC, you will be responsible for:
- Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are informed of developments opportunities and risks that may impact regulatory success.
- Accountable for CMC regulatory strategy for assigned portfolio programs, including but not limited to developing regulatory strategy and plan for CMC development, assessing regulatory scenarios risks and opportunities, proposing risk mitigation measures, and, assessing the probability of regulatory success, and proposing risk mitigation measures.
- Serve as a Regulatory CMC lead on relevant cross-functional or functional teams to provide regulatory guidance and support for CMC development and ensure compliance with applicable EMA/FDA/ICH/WHO/Global regulations and regulatory guidance and guidelines.
- 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, and leading discussions at the CMC focus health authority meetings.
- Accountable for the management and delivery of all CMC regulatory milestones, including global investigational drug filings (e.g., IND / CTA / IMPD / GMO), registrational filings (e.g., BLA, NDS, MAA, and supplements), and responses to health authority questions/requests.
- Responsible for establishing CMC content (data and documentation) requirements for regulatory submissions and reviewing content for conformance with established requirements.
- Evaluate change proposals for regulatory impact and filing requirements.
- Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
- Experience with both US FDA and EMA with drugs and/or biologics is required.
- Prior BLA, sBLA, NDA or sNDA 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.
- A broad understanding of the drug product development process is required.
- This position requires a thorough knowledge of CMC related 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, information, study reports and documents, and providing assessment of technical arguments and conclusions based on the data and analyses.
- Foundational technical knowledge of one or more CMC areas
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate with key stakeholders.
- Effective interpersonal skills to explain complex information in straightforward manner.
- Ability to organize and manage tasks, and leading matrix team works.
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner.
- Strong sense of planning and prioritization, and the ability to work with all levels of management.
- Proficient in Microsoft Office
- Demonstrated track record for successful interactions with FDA and other global health authorities related to CMC development and submissions.
- Good writing and presentation skills.
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Director, Regulatory CMC - Cambridge, United States - Editas Medicine
Description
Job Description
Job DescriptionAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we're committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Position Summary
This role will lead and support the CMC strategies and submission including clinical trials applications, marketing applications, agency briefing packages and response to regulatory authority queries. The Director will incorporate regulatory strategy and well positioned content into high quality submissions to support successful outcomes. The individual will work extensively with cross-functional teams in the execution of these submissions.
Key Responsibilities:
Requirements
Required Qualifications:
The ideal candidate will possess:
Benefits
Benefits Summary:
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.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
