This company is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company has a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
The company is seeking a Director of Regulatory Affairs who will help lead and drive the company's regulatory approval strategy and implementation, as well as overseeing post-approval regulatory requirements. This individual is expected to cultivate productive relationships with regulatory authorities. Leading a small team, this individual is expected interface and effectively communicate with cross-functional members of the Arcellx team. The incumbent fulfills a critical and highly visible role, making substantial contributions to the company.
- Lead program teams in preparing regulatory submissions including briefing documents, IND/CTA/BLA filings, and marketing applications.
- Establish regulatory strategies for programs including non-clinical study plans, regulatory requirements for clinical studies and marketing approvals.
- Act as the primary contact with global regulatory authorities.
- Oversee preparation of responses to all regulatory authority queries
- Plan and lead meeting with regulatory authorities, including end of phase 1/2 meetings.
- A minimum of a Bachelor's and or undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required.
- A minimum of 10+ years of experience inclusive of postgraduate education and/or pharmaceutical or health care industry experience or equivalent is required.
- A minimum of 10 years of experience developing or contributing to global regulatory strategies while working in a regulatory affairs or related function (i.e., R&D, quality, reg compliance) is required.
- Experience in biologics is required.