Vice President, Regulatory Affairs

Job not on LinkedIn

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $280k - $340k / year

⏰ Full Time

🔴 Lead

👔 Vice President

🦅 H1B Visa Sponsor

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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

• Own and drive Loyal's overall regulatory strategy across all active programs, including integrated CMC and clinical regulatory plans from early development through approval and post approval lifecycle management. • Provide regulatory input into portfolio planning, program prioritization, and business development activities. • Develop and maintain global regulatory intelligence capabilities and translate agency expectations, guidance, and industry precedents into actionable strategy. • Provide regulatory updates and risk assessments to executive leadership and the board. • Lead CMC regulatory activities, including filing strategy, CMC section authorship and review, post approval CMC change management, and oversight of manufacturing and CDMO partners. • Partner with CMC and Quality leadership on CDMO regulatory readiness, pre approval inspections, and CMC-related agency interactions. • Lead clinical regulatory activities, including IND strategy and management, protocol regulatory review, study report oversight, and clinical data integration into submissions. • Oversee regulatory strategy for pivotal studies and align study design, endpoints, and agency expectations. • Own approval submission strategy and execution across CMC, Clinical, and Quality, ensuring submission-ready packages reflect agency expectations and eCTD standards. • Serve as Loyal's primary liaison with global regulatory agencies for pre-submission meetings, formal submissions, and ongoing communications. • Manage post approval obligations, including periodic reports, labeling updates, post approval study commitments, and CMC variation filings. • Own labeling strategy and content development throughout the product lifecycle. • Establish and own regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards. • Build and lead a high-performing regulatory organization across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations. • Establish and scale regulatory governance frameworks and procedural documents for submissions, agency meetings, labeling reviews, and regulatory decisions. • Serve as the independent regulatory authority, escalating risks and compliance concerns to executives. • Foster regulatory excellence and proactive risk management across the organization.

🎯 Requirements

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent bio-technical experience and expertise, required. • 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior regulatory leadership roles within sponsor organizations. • Strong CMC regulatory background with deep expertise in small molecule drug development, including OSD formulation, manufacturing process regulatory strategy, CMC section authorship, and post approval change management. • Demonstrated track record of leading regulatory teams spanning both CMC and clinical regulatory functions. • Proven history of successful agency interactions, including pre submission meetings, formal correspondence, and advisory interactions across the product development lifecycle. • Demonstrated experience bringing at least one product to regulatory approval, including NDA, MAA, or equivalent submission leadership. • Required experience with post approval regulatory activities, including CMC change management, labeling updates, periodic safety and annual reports, and post approval study commitments. • Experience building and scaling regulatory organizations in startup or high growth environments. • Strong working knowledge of ICH guidelines and regulatory requirements across relevant global markets. • Executive presence with the ability to serve as the company's primary regulatory authority and represent Loyal credibly with regulatory agencies and senior external stakeholders. • Primary experience in human health pharmaceutical or biotech environments strongly preferred; animal health experience is a plus. • Experience with FDA CVM regulations and the veterinary drug approval pathway (NADA/ANADA), or demonstrated ability to develop expertise in a novel regulatory framework quickly. • Experience filing with and interacting with the EMA and major Asian regulatory agencies (PMDA, NMPA, or equivalents) is a significant plus. • Experience supporting first commercial launches and establishing post approval regulatory infrastructure in a company scaling toward commercialization. • Familiarity with eCTD submission standards and regulatory operations best practices for late stage development companies. • Experience leading organizations through significant growth, transformation, or regulatory milestone events. • Strong systems thinking mindset with a disciplined, risk based approach to regulatory strategy and decision-making.

🏖️ 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