Full-Time

Director/Senior Director

Regulatory Affairs, Therapeutics

Confirmed live in the last 24 hours

Mammoth Biosciences

Mammoth Biosciences

51-200 employees

Develops CRISPR gene editing technologies

Food & Agriculture
Data & Analytics
AI & Machine Learning
Aerospace
Biotechnology

Senior

Daly City, CA, USA

Requirements
  • Bachelor’s degree in life sciences
  • Minimum of 10+ years of experience in the biotechnology and/or biopharmaceutical industry
  • Experience with US and clinical trial submissions through with CBER/OTAT or ex-US equivalent
  • Strong project management skills and drive for excellence
  • Experience with gene therapy products regulatory requirements
  • Proven success interacting efficiently with Preclinical Research, CMC, and Clinical
Responsibilities
  • Lead, define and manage the strategic regulatory direction for Mammoth's pipeline
  • Establish the regulatory pathway to IND filing in complex programs using a novel gene editing technology
  • Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge of US and EU
  • Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities
  • Serve as a liaison between the company and regulatory agencies
  • Maintain real-time understanding of Mammoth's target patient population
  • Develop and coordinate high-quality submissions for global clinical trials

Mammoth Biosciences specializes in leveraging its proprietary ultracompact CRISPR systems for long-term curative therapies and decentralized precision diagnostics, enabling in vivo gene editing in difficult-to-reach tissues and offering nuclease applications, base editing, gene writing, and epigenetic editing.

Company Stage

Series D

Total Funding

$264.5M

Headquarters

Brisbane, California

Founded

2017

Growth & Insights
Headcount

6 month growth

3%

1 year growth

0%

2 year growth

18%

Benefits

Medical, dental, & vision

401(k)

Unlimited vacation

Transportation subsidy

Onsite amenities

Happy hours