Full-Time

Director – Regulatory CMC

Confirmed live in the last 24 hours

Editas Medicine

Editas Medicine

201-500 employees

Develops CRISPR-based gene editing therapies

Biotechnology

Senior

Cambridge, MA, USA

Requirements
  • Bachelor’s degree in a scientific discipline
  • Minimum of 10 years’ experience in drug development/regulatory affairs
  • Minimum 8 years in CMC regulatory affairs
  • Experience with US FDA and EMA with drugs and/or biologics
  • Prior BLA, sBLA, NDA or sNDA experience
  • Prior IND, CTA and IMPD experience
  • Experience with the regulation of biologics
  • Broad understanding of drug product development process
  • Thorough knowledge of CMC related guidance and guidelines
  • GMP requirements knowledge
  • Understanding of clinical ICH Good Clinical Practice Guidelines
  • Foundational technical knowledge of one or more CMC areas
  • Demonstrated ability to generate innovative solutions to complex regulatory problems
  • Effective interpersonal skills
  • Ability to organize and manage tasks
  • Strong sense of planning and prioritization
  • Proficient in Microsoft Office
  • Good writing and presentation skills
Responsibilities
  • Provide CMC expertise in regulatory affairs organization
  • Accountable for CMC regulatory strategy for assigned portfolio programs
  • Serve as Regulatory CMC lead on cross-functional teams
  • Lead CMC related interactions with health authorities
  • Manage and deliver all CMC regulatory milestones
  • Establish CMC content requirements for regulatory submissions
  • Evaluate change proposals for regulatory impact

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

16%

1 year growth

28%

2 year growth

19%