What are the responsibilities and job description for the Regulatory Affairs Leader position at Mammoth Biosciences?
Mammoth Biosciences is a biotechnology company dedicated to transforming the lives of patients through innovative CRISPR technologies. We are seeking an experienced Director/Senior Director, Regulatory Affairs, Therapeutics to lead our regulatory activities and drive the development of our therapeutic programs.
Key Responsibilities:
- Develop and execute strategic regulatory plans to support our pipeline of in vivo gene editing therapeutics.
- Establish and maintain relationships with regulatory authorities, including the FDA and EMA.
- Collaborate with cross-functional teams, including clinical research, CMC, and nonclinical research personnel.
- Provide guidance on regulatory compliance and ensure adherence to industry standards and guidelines.
- Develop and coordinate high-quality submissions for global clinical trials.
Qualifications:
- Bachelor's degree in life sciences or related field.
- Minimum 10 years of experience in the biotechnology and/or biopharmaceutical industry.
- Proven track record of success in regulatory affairs, with experience in drug development and submission to regulatory agencies.
- Strong project management skills and ability to work in a fast-paced environment.
