Junto HLS has been engaged by Sr. Leadership at a Bay Area biotech to recruit a Director/ Associate Director, Regulatory Affairs CMC.
- Biologics experience preferred.
- Must have BS/BA in life sciences or equivalent; advanced degree preferred.
- Excellent interpersonal and communication skills.
- Works with Senior Leadership to develop CMC regulatory strategies for biopharmaceutical products in development.
- Represents RA at project team meetings and coordinates workflow between departments as well as CROs.
- Responsible for interactions with regulatory authorities as needed.
- Coordinate all CMC aspects of global regulatory submissions.
- Participates in department initiatives to improve standards and systems internally and maintain relationships with other departments including consultants and vendors.
- Greater San Francisco Bay Area, CA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.