Senior Associate Specialist, Regulatory Operations

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🔥 13 minutes ago

🇺🇸 United States – Remote

💵 $110k - $160k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Loyal

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Loyal is a comprehensive digital healthcare platform that integrates various touchpoints for patients and providers. Their solutions include data management, digital engagement, CRM campaigns, self-scheduling, and conversational AI, which are designed to optimize healthcare operations, improve patient engagement, and enhance care search and scheduling. Loyal focuses on making healthcare seamless by unifying provider and location data, managing reputation and directory listings, and offering robust machine learning and natural language processing capabilities to improve healthcare outcomes. The platform facilitates improved communication and retention through omni-channel engagement and feedback analysis, serving prominent healthcare organizations to streamline operations and drive better patient experiences.

📋 Description

• Assist in preparing and reviewing both Clinical and CMC regulatory submissions and reports • Create and package submissions in the CVM eSubmitter tool from author-drafted Word sections and return eSubmitter output for author review • Assemble, format, and publish submissions to FDA CVM and ex-US agencies, including INAD/JINAD correspondence, technical sections, amendments, annual reports, and meeting requests • Manage transmission through the FDA Electronic Submissions Gateway, including account administration, receipt reconciliation, and troubleshooting failed transmissions • Maintain the submission archive and correspondence log for prior commitments, agency comments, and filed documents • Own regulatory document templates and the submission style guide • Create and maintain submission trackers and keep the regulatory activity source of truth current • Collaborate with internal teams on product labeling and documentation • Stay current on changes to FDA CVM and, if applicable, ex-US authorities • Report to the Head of Regulatory, CMC

🎯 Requirements

• Bachelor’s degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience > specific degree • 3-5 years of regulatory ops experience in human or animal health; animal health preferred • Knowledge of various regulatory submission types (H-submissions, Z-submissions, etc.) • Hands-on experience drafting, packaging, and submitting regulatory submissions and communications to the FDA via the ESG electronic submission system • Familiarity with ex-US submissions preferred but not required • Ability to collaborate with cross-functional Research, Clinical, and CMC teams • Ability to operate with autonomy and accountability when managing submissions • RAPS certification is a bonus but is not required • Interest in working at the forefront of regulatory category creation

🏖️ Benefits

• Full-coverage health insurance — medical, dental and vision — 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. • All 3-day weekends are turned into 4-day weekends • Unlimited vacation and paid holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member • Competitive salary • Company equity options grant for new hires