Loyal
Vice President, CMC Regulatory Affairs
$280K–$340K
Remote - US +1 · Remote · Director · Full-time · Posted Oct 2, 2026
- Location
- Remote - US
Remote - Experience
- 18+ years in regulatory affairs, including 10+ years in senior regulatory leadership roles within sponsor organizations.
- Education
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent bio-technical experience and expertise.
About the job
Leads Loyal’s global CMC regulatory strategy and operations across its veterinary drug pipeline, from development through approval and post-approval lifecycle management.
What you'll do
- Own CMC filing strategy, submission content, agency interactions, and post-approval regulatory obligations.
- Build and lead the CMC regulatory organization, infrastructure, governance, and procedures.
- Advise executive leadership on regulatory strategy, feasibility, and risk; coordinate with CMC, Quality, and other teams.
What they ask for
- 18+ years of progressive regulatory affairs experience, including 10+ years in senior regulatory leadership roles within sponsor organizations.
- Deep small-molecule CMC expertise, including OSD formulation, manufacturing-process strategy, submission authorship, and post-approval change management.
- Track record leading CMC regulatory teams, successful agency interactions, and bringing at least one product to approval (NDA, MAA, or equivalent).
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent bio-technical experience and expertise.
Nice to have
- Primary experience in human health pharmaceutical or biotech environments; animal health experience is a plus.
- Experience with FDA CVM and veterinary drug approvals (NADA/ANADA), or with EMA and major Asian agencies (PMDA, NMPA, or equivalents).
Pay
$280,000 - $340,000 (base salary)
Tools
ICH guidelines, eCTD, FDA CVM, NADA, ANADA, EMA, PMDA, NMPA
Model-written summary · the original posting is authoritative