Manager, Regulatory Affairs

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.

Position Summary

The Regulatory Affairs Manager, reporting to the Senior Director, Regulatory Affairs, will provide operational support on strategic regulatory deliverables critical to Editas Medicine’s In Vivo and Ex Vivo Gene Therapy programs. This person will partner with the Regulatory Lead in preparation of health authority interactions and play a key role in ensuring operational excellence for our RA strategy & policy. This individual will need to leverage industry expertise in these efforts to ensure operational preparedness for future regulatory filings.

Key Responsibilities & Accountabilities:

• Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
• Maintain tracking data for health authority meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports
• Provide operational support on strategic regulatory documents to help drive timely deliverables
• Drive operational excellence in Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency
• Additional responsibilities, in conjunction with regulatory leads and regulatory CMC lead, include BLA maintenance submissions
• Safety and Annual report submissions (regulatory components)
• Coordinating and drive rapid response team meetings to ensure quality and timely responses to health authority queries. This includes the preparation of response to HA queries according to the rapid response process.
• Maintaining global submission plans and supporting those plans can be executed on time
• Coordinating and driving global regulatory sub team meetings to ensure high quality meeting discussions & outputs; this includes diligent follow-up with sub team members to uphold accountabilities and drive decision-making

Knowledge, Skills & Capabilities:

• Ability to rapidly adapt to different issues and projects at one time. Expert in planning and delivering work on time keeping quality parameter in mind;
• Knowledge of regulatory procedures in appropriate region
• Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
• Ability to recognize, articulate, and accept calculated risks to make informed decisions
• Develop understanding of different TAs due to assignment to different projects.
• Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape.

• Increased exposure to global and multi-functional teams.
• Good working knowledge of regional regulatory intelligence;
• Ability to work closely with client regional heads to determine the Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable;
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
• Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, publishing projects
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
• Proficient with relevant submission software, including but not limited to, Veeva, Adobe Acrobat, Microsoft Office, eCTD viewers.

Education & Relevant Work Experience:

• Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine).
• Bachelor’s degree in related discipline and a minimum of 5 years of related experience; or
• Master’s degree in related discipline and a minimum of 3+ years of related experience; or
• PhD degree in related discipline and a minimum of 2 years of related experience; or Equivalent combination of education and experience
• Demonstrates a high-level of self-motivation and professional commitment.

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.