[Remote] Director, Regulatory Affairs - Clinical

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage veterinary medicine company developing longevity drugs for dogs. The Director of Regulatory Affairs, Clinical will serve as the subject matter expert on FDA regulatory reputed company and manage reputed company regulatory programs to bring novel therapeutics to market.

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 reputed company reputed company-time regulatory guidance on reputed company studies, including SAE submissions, BIMO preparedness, and NCIE reports
• Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest reputed company submissions for pivotal protocol concurrence
• Monitoring and interpreting CVM guidance, policy updates, and precedent to inform reputed company's regulatory reputed company across our pipeline
• Anticipating and resolving regulatory risks across functions (including R&D, CMC, and reputed company) throughout the portfolio before they become problems
• Managing and mentoring 1–2 reputed company reports, providing feedback, priorities, and development support
• Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and reputed company teams on submissions and reputed company
• reputed company the maintenance and organization of reputed company regulatory records and interactions reputed company to reputed company’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 reputed company facing reputed company-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

Skills

• Bachelor's degree in relevant field (biology, vet med, regulatory affairs or reputed company); relevant experience > specific degree
• 10+ years of regulatory affairs experience with 3+ years in animal reputed company 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.)
• You are data-driven and an analytical thinker; your regulatory experience is grounded in evidence and you communicate with reputed company
• Strong and reputed company reputed company that takes pride in reputed company, accuracy and persuasive story telling about biological reputed company or drug mechanisms and clinical impacts
• Extensive knowledge of FDA CVM regulatory reputed company, policies, and limitations and where there are areas to reputed company reputed company those bounds
• Excellent judgement where FDA CVM is concerned and comfortable being the single reputed company of strategic conviction using that judgement
• reputed company 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
• reputed company by a fast-paced startup environment

Benefits

• Full-coverage health insurance — medical, dental and reputed company — for you and your dependents
• $1,000 home office equipment stipend
• $1,200/year learning budget for books, courses, etc.
• $250/month wellness budget for gym, cleaners, spa, food, etc.
• reputed company 3-day weekends are turned into 4-day weekends 🎉
• Unlimited vacation and reputed company holidays
• Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
• Company equity reputed company grant for new hires

reputed company