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Regulatory Affairs Director
2 months ago
Mammoth Biosciences is seeking a highly experienced Regulatory Affairs Director to lead the regulatory activities of our growing CRISPR-based therapeutic programs. This role will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings.
Key Responsibilities:- Establish the regulatory pathway to IND filing in complex programs using a novel gene editing technology
- Collaborate with 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 to 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
- Bachelor's degree in life sciences
- Minimum of 10+ years of experience in the biotechnology and/or biopharmaceutical industry
- Minimum of 7 years in a Regulatory capacity with experience in drug development
- Experience with US and clinical trial submissions through CBER/OTAT or ex-US equivalent
- Proven track record with regulatory agencies
- Advanced degree in life sciences
- Creative problem solver
- Company-paid health/vision/dental benefits
- Unlimited vacation and generous sick time
- Company-sponsored meals and snacks
- Wellness, caregiver, and ergonomics benefits
- 401(k) with company matching
Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies and other applications. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company's ultracompact proteins are designed to enable in vivo gene editing in difficult-to-reach tissues using both nuclease applications and new editing modalities beyond double-stranded breaks.
The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology.
Mammoth's deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies.
Mammoth Biosciences requires that all employees be vaccinated against COVID-19 as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law.
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