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Summary
About the Role
About You
- Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science.
- 12+ years of relevant experience with a bachelor's degree or 10+ years with an advanced degree for Associate Director; 15+ years with a bachelor's degree or 12+ years with an advanced degree for Director.
- Thorough knowledge of pharmaceutical and/or biological product development and regulatory requirements in multiple key regions (EU, US, New Zealand, Australia).
- Experience interfacing with regulatory agencies and developing successful global regulatory strategies.
- Strong analytical skills and ability to present complex data clearly.
- An advanced degree (MS/MBA, PhD or MD).
- Experience developing new product regulatory strategies from early development through marketing applications.
- Working knowledge of cellular and gene therapies or biologics development.
- Detailed knowledge of regulatory document preparation for INDs, CTAs, BLAs, and annual reports.
- Experience in a small biotech environment.
Benefits
- Dynamic workplace with remote work flexibility.
- Collaborative work environment with mentorship opportunities.
- Equal employment opportunity and non-discrimination commitment.
Since its inception over a decade ago, CRISPR Therapeutics has evolved from a research-stage company advancing gene editing programs into a leader that celebrated the historic approval of the first-ever CRISPR-based therapy. The Company has a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular, autoimmune, and rare diseases. In 2018, CRISPR Therapeutics advanced the first-ever CRISPR/Cas9 gene-edited therapy into the clinic to investigate the treatment of sickle cell disease and transfusion-dependent beta thalassemia. Beginning in late 2023, CASGEVY® (exagamglogene autotemcel [exa-cel]) was approved in several countries to treat eligible patients with either of these conditions. The Nobel Prize-winning CRISPR technology has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has formed strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.