Director, Regulatory Affairs - Clinical
L
LoyalVeterinary Medicine
Remote - USFull-TimeDirector
Salary155000 - 205000 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- 10+ years
Requirements
- Bachelor’s degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience > specific degree
- 10+ years of regulatory affairs experience in animal health with direct experience with owning FDA CVM relationships
- Hands on ownership experience with INADs, regulatory submissions, and FDA CVM in-person meetings
- Background across multiple drug types ideal (small molecules, biologics, injectables, etc.)
- Data-driven and an analytical thinker; regulatory experience grounded in evidence and communicated with excellence
- Strong and experienced writer that takes pride in clarity, accuracy and persuasive storytelling about biological pathways or drug mechanisms and clinical impacts
- Extensive knowledge of FDA CVM regulatory pathways, policies, and limitations and where there are areas to innovate within those bounds
- Excellent judgement where FDA CVM is concerned and comfortable being the single source of strategic conviction using that judgement
- Collaborative with cross-functional teams and not afraid to be in the weeds while also being the subject matter expert
- Ability to operate as a high level individual contributor while also serving as a mentor to junior team members in order to upskill the department
- Energized by a fast-paced startup environment
Responsibilities
- Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence
- Leading preparation for FDA CVM meetings, including briefing documents, meeting requests, posing questions, and follow-up MOCs
- Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports
- Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence
- Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline
- Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems
- Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support
- Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy
- Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs
- Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting
- Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations
- Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations
View Full Description & ApplyYou'll be redirected to the employer's site
