Full-Time

Senior Manager

Regulatory Affairs

Posted on 5/3/2024

Editas Medicine

Editas Medicine

201-500 employees

Develops CRISPR-based gene editing therapies

Biotechnology

Senior

Cambridge, MA, USA

Requirements
  • Bachelor’s degree in life science (BS) required
  • Advanced degree preferred
  • Minimum of 7+ years’ experience in drug development
  • Minimum of 4+ years in regulatory affairs
  • Prior BLA, sBLA, NDA, sNDA, or MAA experience preferred
  • Prior IND, CTA, and IMPD experience required
  • Experience with regulation of biologics essential
  • Experience with gene editing and/or cell and gene therapy preferred
  • Proficiency in Microsoft Office, regulatory information management systems (RIMS), and project management tools mandatory
  • Strategic, analytical, and process-oriented with attention to detail
  • Strong planning, organizational, and execution skills
  • Ability to develop and apply innovative solutions
  • Excellent verbal and written communication skills
  • Ability to work collaboratively in a cross-functional/global team setting
Responsibilities
  • Manage Regulatory eCTD Content Planner for major filings
  • Monitor and interpret relevant regulations, guidelines, and industry trends
  • Stay abreast of changes in regulatory requirements and guidelines
  • Support the development and maintenance of quality systems related to regulatory affairs
  • Support the regulatory lead in the creation and implementation of regulatory strategies
  • Prepare for Health Authority meetings with agencies
  • Collaborate with cross-functional teams to provide regulatory guidance
  • Identify regulatory risks and develop mitigation strategies

Editas Medicine is a leader in the biotechnology industry, focused on developing cutting-edge CRISPR gene editing technologies to create transformative medicines for serious diseases. This focus places the company at the forefront of genetic research and therapy development, providing a dynamic and pioneering environment for its employees. As a workplace, it promises a culture of constant learning and innovation, ideal for those passionate about advancing healthcare and contributing to vital medical breakthroughs.

Company Stage

IPO

Total Funding

$884.6M

Headquarters

Cambridge, Massachusetts

Founded

2013

Growth & Insights
Headcount

6 month growth

15%

1 year growth

27%

2 year growth

18%