Job Details
Senior Director/Executive Director, Regulatory Affairs
*Onsite 2-3 days weekly in South San Francisco, CA*
Meet has partnered with a pre-IPO biotech that is looking for a Head of Regulatory Affairs to join their team. This will be the first full-time RA hire for the organization and you will be reporting directly into the CEO. Our client is based in South SF and is focused within hematology/oncology, with a promising early development pipeline in the biologics space.
Key Responsibilities
- Develop and execute regulatory strategies to streamline the development and approval of innovative medicines
- Lead the preparation of relevant regulatory submissions (IND/CTA + BLA/MAA)
- Provide regulatory guidance to cross-functional teams in support of clinical pipeline development
Key Qualifications
- Minimum 12 years of relevant industry experience
- Biologics background highly preferred
- Experience leading programs from Pre-IND through BLA
- Experience in hematology/oncology highly preferred
Please reach out to Ryan Moran to learn more:
Email: ...@peoplewithchemistry.com