Senior Manager, Regulatory Affairs

Editas Medicine

Editas Medicine

Legal, Sales & Business Development
Cambridge, MA, USA
Posted on Saturday, May 4, 2024

At 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

As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting the execution of our regulatory strategy for our programs in clinical development. You will collaborate closely with the global regulatory lead and cross-functional teams to navigate complex regulatory requirements and facilitate the successful development, registration, and commercialization of our products.

Key Responsibilities:

As the Senior Manager, Regulatory Affairs, you will be responsible for:

  • Regulatory Submissions: Manage the Regulatory eCTD Content Planner for major filings, including investigational new drug applications (INDs), biologics license applications (BLAs), and marketing authorization applications (MAAs), tracking timelines and availability of deliverables from cross functional team to ensure accuracy, completeness, and timeliness. Escalate critical path items to relevant stakeholders as needed. Deep experience with Project Management tools such as SmartSheet, ThinkCell and/or Microsoft Project is key.
  • Regulatory Compliance: Monitor and interpret relevant regulations, guidelines, and industry trends to ensure compliance with applicable regulatory requirements throughout product lifecycle. Develop internal best practices, work instructions and Standard Operating Procedures (SOP) as needed for the regulatory organization. Develop and oversee timelines for regulatory compliance reports for assigned programs (eg. IND/BLA Annual Reports, Orphan Drug Designation Annual Reports, etc.) to ensure timely submission to regulatory authorities.
  • Regulatory Intelligence: Stay abreast of changes in regulatory requirements and guidelines, assess their impact on product development and registration strategies, and communicate relevant updates to internal stakeholders.
  • Quality Systems Support: Support the development and maintenance of quality systems related to regulatory affairs (e.g. Regulatory Information Management Systems (RIMS)), including document management, training, and SOP development, to ensure compliance with regulatory requirements. Experience with Veeva RIMS is preferred.
  • Regulatory Strategy Development: Support the regulatory lead in the creation and implementation of regulatory strategies for product development and registration in alignment with business objectives and regulatory requirements.
  • Regulatory Agency Interactions: Support the regulatory lead in preparing for Health Authority meetings with agencies, including the FDA, EMA, and other global regulatory authorities, representing the company in regulatory interactions, meetings, and submissions. Develop and oversee timelines for authoring of meeting materials (meeting request, briefing document, etc.), to ensure timely execution of high-quality documents by cross functional team.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams, including Clinical Development, Nonclinical Development, Quality Assurance, Analytical Development, Manufacturing, and Legal, to provide regulatory guidance and support for product development, manufacturing, and commercialization activities.
  • Risk Management: Identify regulatory risks and develop mitigation strategies to proactively address potential issues that may impact product development or regulatory approval.