California Licensed Regulatory Affairs Manager

Job Summary

Hands-on and strategic, the full-time California Licensed Regulatory Affairs Manager will develop and execute global regulatory CMC strategies for investigational products, manage regulatory submissions, and collaborate with cross-functional teams while working remotely.

Key responsibilities:

• Represent Regulatory Affairs in internal project teams and provide regulatory positions on CMC topics
• Manage the preparation and submission of regulatory CMC documentation, ensuring compliance with regulatory agency commitments
• Collaborate with cross-functional teams to develop regulatory strategies and assess regulatory risks

Required qualifications:

• Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, or related field)
• 9+ years of experience in the vaccine or biotech industry, or equivalent education and experience
• Prior experience preparing/authoring CMC sections for BLA or IND submissions
• Familiarity with module 32S and 32P
• Experience with software tools such as LIMS, SAP, TrackWise, and Veeva