Loyal is a clinical-stage veterinary medicine company working on giving dogs longer, healthier lives. Backed by Khosla.
About the role
Loyal is seeking a Vice President, CMC Regulatory Affairs to lead the strategy and operations across all the CMC regulatory activities. This leader will own the full CMC regulatory program across Loyal's pipeline, from early development through approval and into post approval lifecycle management. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent bio-technical experience and expertise required
- 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior regulatory leadership roles within sponsor organizations
- Strong CMC regulatory background with deep expertise in small molecule drug development, including OSD formulation, manufacturing process regulatory strategy, CMC section authorship, and post approval change management
- Demonstrated track record of leading CMC regulatory teams
- Proven history of successful agency interactions, including pre submission meetings, formal correspondence, and advisory interactions across the product development lifecycle
- Demonstrated experience bringing at least one product to regulatory approval, including NDA, MAA, or equivalent submission leadership
More about this role
Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.
We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress toward our first regulatory approvals, with additional submissions targeted in the near future.
Loyal is a well-funded startup . You'll help us continue our path of earning regulatory approval for the first lifespan extension medicine for any species and change what's possible for the dogs we love.
Loyal is seeking a Vice President, CMC Regulatory Affairs to lead the strategy and operations across all the CMC regulatory activities. This leader will own the full CMC regulatory program across Loyal's pipeline, from early development through approval and into post approval lifecycle management.
A strong CMC regulatory background is essential. The ideal candidate brings deep expertise in small molecule drug development, ideally from human health, with a proven track record leading CMC...
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