Vice President, Regulatory Affairs

LoyalVeterinary medicine

Location: Remote - USFull-TimeVp

Salary$280,000 - $340,000

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Job Details

Experience: 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior regulatory leadership roles within sponsor organizations.

Hold a Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or have equivalent bio-technical experience and expertise.
Bring 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments.
Have 10+ years in senior regulatory leadership roles within sponsor organizations.
Demonstrate deep CMC regulatory expertise in small-molecule drug development, including OSD formulation, manufacturing process strategy, CMC section authorship, and post-approval change management.
Have a track record leading regulatory teams across CMC and clinical regulatory functions.
Demonstrate successful agency interactions, including pre-submission meetings, formal correspondence, and advisory interactions.
Have led at least one product to regulatory approval, including NDA, MAA, or equivalent submission leadership.
Have experience with post-approval activities, including CMC change management, labeling updates, periodic safety and annual reports, and post-approval study commitments.
Have experience building and scaling regulatory organizations in startup or high-growth environments.
Have strong working knowledge of ICH guidelines and regulatory requirements across relevant global markets.
Human health pharmaceutical or biotech experience is preferred; animal health experience is a plus.
Experience with FDA CVM regulations and the NADA/ANADA veterinary drug approval pathway, EMA, or major Asian regulatory agencies is preferred.

Own regulatory strategy across active programs, integrating CMC and clinical plans with development milestones and commercial objectives.
Provide regulatory input to portfolio planning, program prioritization, and business development.
Develop regulatory intelligence capabilities and communicate regulatory updates and risk assessments to executive leadership and the board.
Lead CMC regulatory activities, including filing strategy, CMC section authorship and review, change management, and oversight of manufacturing and CDMO partners.
Lead clinical regulatory activities, including IND strategy and management, protocol review, study report oversight, and integration of clinical data into submissions.
Own approval submission strategy and execution, coordinating submission-ready packages across CMC, Clinical, and Quality.
Serve as the primary liaison with regulatory agencies, leading pre-submission meetings, formal submissions, and ongoing communications.
Manage post-approval obligations, including periodic reports, labeling updates, study commitments, and CMC variation filings.
Establish regulatory information management, eCTD publishing, submission archiving, and procedural standards.
Build and lead the regulatory organization and establish governance across CMC regulatory, clinical regulatory, submissions, labeling, and regulatory operations.

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