Regulatory Affairs Director
2 weeks ago
Mammoth Biosciences is seeking a seasoned Regulatory Affairs professional to lead the regulatory strategy for our growing CRISPR-based therapeutic programs. As a key member of our team, you will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings. This leadership role will play a critical part in the successful development of our therapeutic candidates.
Key Responsibilities:- Develop and manage the strategic regulatory direction for our pipeline
- Establish the regulatory pathway to IND filing in complex programs using 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 a real-time understanding of our target patient population
- Develop and coordinate high-quality submissions for global clinical trials
- Bachelor's degree in life sciences
- Minimum of 10+ years of experience in the biotechnology and/or biopharmaceutical industry (Master's degree with 8+ years of experience or PhD with 6+ years of experience)
- 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
- 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
- Ability to be onsite a minimum of 2-3x/ per week from a reasonable commuting distance within the Bay Area
- 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
Base Salary Range: $205,000 - $260,000. Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity.
Mammoth Biosciences is an equal opportunity employer and welcomes applications from diverse candidates. We require all employees to 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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Regulatory Affairs Director
4 days ago
Brisbane, California, United States Mammoth Biosciences Full timeLead Regulatory Affairs for Therapeutic ProgramsMammoth Biosciences is seeking a seasoned Regulatory Affairs professional to lead the regulatory activities of our growing CRISPR-based therapeutic programs. As Director/Senior Director, Regulatory Affairs, Therapeutics, you will be responsible for coordinating all aspects of regulatory strategy, interactions,...
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Regulatory Affairs Director
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Brisbane, California, United States Mammoth Biosciences Full timeJob Title: Director/Senior Director, Regulatory Affairs, TherapeuticsMammoth Biosciences is seeking a highly experienced and skilled Director/Senior Director, Regulatory Affairs, Therapeutics to lead the regulatory activities of our growing CRISPR-based therapeutic programs. This role will be responsible for coordinating all aspects of regulatory strategy,...
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Regulatory Affairs Director
21 hours ago
Brisbane, California, United States Mammoth Biosciences Full time{"title": "Regulatory Affairs Director", "content": "Lead Regulatory Affairs for Therapeutic ProgramsMammoth 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,...
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Regulatory Affairs Director
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Brisbane, California, United States Mammoth Biosciences Full timeJob Title: Director/Senior Director, Regulatory Affairs, TherapeuticsMammoth Biosciences is seeking a seasoned regulatory professional to lead the regulatory activities of our growing CRISPR-based therapeutic programs. As a key member of our team, you will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings. This...
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Brisbane, California, United States Mammoth Biosciences Full timeJob SummaryMammoth Biosciences is seeking a highly experienced Regulatory Affairs Director/Senior Director, Therapeutics 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 ResponsibilitiesRegulatory Strategy and...
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Brisbane, California, United States Mammoth Biosciences Full timeJob SummaryMammoth Biosciences is seeking a highly experienced Regulatory Affairs Director/Senior 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 ResponsibilitiesRegulatory Strategy and Planning:...
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Brisbane, California, United States Mammoth Biosciences Full timeJob SummaryMammoth Biosciences is seeking a highly experienced Director/Senior Director, Regulatory Affairs, Therapeutics to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.Key ResponsibilitiesLead, define and manage the strategic regulatory direction for Mammoth's pipelineEstablish the...
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Brisbane, California, United States Mammoth Biosciences Full timeJob Summary:Mammoth Biosciences is seeking a highly experienced Director/Senior Director, Regulatory Affairs, Therapeutics 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:Lead, define and manage...
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