Vice President, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership and lead Loyal's comprehensive regulatory strategy across all ongoing programs, encompassing integrated CMC and clinical regulatory plans from initial development through approval and post-approval lifecycle management.

• Provide regulatory insights for portfolio planning, program prioritization, and business development initiatives.

• Develop and sustain global regulatory intelligence capabilities, translating agency expectations, guidance, and industry precedents into actionable strategies.

• Deliver regulatory updates and risk assessments to executive leadership and the board of directors.

• Direct CMC regulatory activities, including strategy for filings, authorship and review of CMC sections, management of post-approval CMC changes, and oversight of manufacturing and CDMO partners.

• Collaborate with CMC and Quality leadership on CDMO regulatory readiness, pre-approval inspections, and CMC-related agency interactions.

• Lead clinical regulatory efforts, including IND strategy and management, regulatory review of protocols, oversight of study reports, and integration of clinical data into submissions.

• Supervise regulatory strategy for pivotal studies, ensuring alignment of study design, endpoints, and agency expectations.

• Own the strategy and execution for approval submissions across CMC, Clinical, and Quality, ensuring submission-ready packages meet agency expectations and eCTD standards.

• Act as Loyal's primary point of contact with global regulatory agencies for pre-submission meetings, formal submissions, and ongoing communications.

• Manage post-approval obligations, such as periodic reports, labeling updates, commitments for post-approval studies, and CMC variation filings.

• Develop and oversee labeling strategy and content throughout the product lifecycle.

• Establish and manage the regulatory information management infrastructure, eCTD publishing capabilities, and submission archiving standards.

• Build and lead a high-performing regulatory organization encompassing CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations.

• Create 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 issues to executives.

• Promote regulatory excellence and proactive risk management throughout the organization.

⛳️ Requirements

• A Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific field, or equivalent biotechnical experience and expertise, is required.

• 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech settings, with at least 10 years in senior regulatory leadership roles within sponsor organizations.

• Strong background in CMC regulatory affairs with extensive expertise in small molecule drug development, including OSD formulation, regulatory strategy for manufacturing processes, CMC section authorship, and management of post-approval changes.

• Proven experience in leading regulatory teams across both CMC and clinical regulatory functions.

• Established history of successful interactions with regulatory agencies, including pre-submission meetings, formal correspondence, and advisory engagements throughout the product development lifecycle.

• Demonstrated experience in leading at least one product to regulatory approval, including NDA, MAA, or equivalent submission leadership.

• Required experience in post-approval regulatory activities, such as CMC change management, labeling updates, periodic safety and annual reports, and commitments for post-approval studies.

• Experience in 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 capability to act 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 is strongly preferred; experience in animal health is a plus.

• Familiarity with FDA CVM regulations and the veterinary drug approval pathway (NADA/ANADA), or the ability to quickly develop expertise in a novel regulatory framework.

• Experience in filing with and engaging with the EMA and major Asian regulatory agencies (PMDA, NMPA, or equivalents) is a significant advantage.

• Experience in supporting first commercial launches and establishing post-approval regulatory infrastructure in a company transitioning toward commercialization.

• Understanding of eCTD submission standards and regulatory operations best practices for late-stage development companies.

• Experience leading organizations through significant growth, transformation, or milestones in regulatory events.

• A strong systems thinking mindset with a disciplined, risk-based approach to regulatory strategy and decision-making.

🏝️ Benefits

• Comprehensive health insurance coverage — medical, dental, and vision — for you and your dependents.

• $1,000 stipend for home office equipment.

• Annual learning budget of $1,200 for books, courses, and additional educational resources.

• Monthly wellness budget of $250 for gym memberships, cleaners, spa services, food, and more.

• All 3-day weekends are extended to 4-day weekends.

• Unlimited vacation time along with paid holidays.

• Paw-ternity leave — adopt a dog and receive a day off to spend with your new family member.

• Competitive salary.

• Company equity options granted to new hires.