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Senior Director/Executive Director, Regulatory Affairs

, CA, United States

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: [email protected]

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