About the roleLoyal is seeking a Vice President, Regulatory Affairs to lead all aspects of the company's regulatory function, spanning strategy and operations across CMC and clinical regulatory activities. This leader will own the full regulatory program across Loyal's pipeline, from early development through approval and into post approval lifecycle management.
A strong CMC regulatory background is essential. The ideal candidate brings deep expertise in small molecule drug development, ideally from human health, with a proven track record leading integrated regulatory teams, executing successful agency interactions, and bringing products to approval. Demonstrated experience in post approval regulatory activities is required.
This role requires both strategic vision and operational execution. The successful candidate will build and lead a regulatory organization capable of supporting Loyal across all stages of development and into a commercial company, and will serve as the primary regulatory authority and the company's primary interface with regulatory agencies globally.
The role reports to senior executive leadership and partners closely with leadership across TechOps, Quality, Clinical, Operations, and Commercial.
Your daily work will include- Own and drive Loyal's overall regulatory strategy across all active programs, including integrated CMC and clinical regulatory plans aligned with development milestones and commercial objectives, from early development through approval and post approval lifecycle management.
- Provide regulatory input into portfolio planning, program prioritization, and business development activities, ensuring regulatory feasibility and risk are embedded in key decisions.
- Develop and maintain global regulatory intelligence capabilities, monitoring evolving agency expectations, guidance documents, and industry precedents relevant to Loyal's programs and translating these into actionable strategy.
- Provide regular regulatory updates and risk assessments to executive leadership and the board on submission progress, agency interactions, and regulatory risk.
- Lead all CMC regulatory activities including filing strategy, CMC section authorship and review, post approval CMC change management, and regulatory oversight of manufacturing and CDMO partners.
- Ensure CMC regulatory strategy reflects current agency expectations for small molecule OSD products and is integrated with CMC development plans and manufacturing timelines.
- Partner with CMC and Quality leadership on CDMO regulatory readiness, including preparation for pre approval inspections and CMC related agency interactions.
- Lead clinical regulatory activities including IND strategy and management, protocol regulatory review, study report oversight, and integration of clinical data into regulatory submissions.
- Oversee regulatory strategy for pivotal studies and ensure alignment between study design, endpoints, and agency expectations to support a strong approval package.
- Own the approval submission strategy and execution, coordinating across CMC, Clinical, and Quality to ensure submission ready packages that reflect current agency expectations and eCTD standards.
- Serve as the company's primary liaison with regulatory agencies globally, leading the planning and execution of pre submission meetings, formal submissions, and ongoing agency communications.
- Manage post approval regulatory obligations including periodic reports, labeling updates, post approval study commitments, and CMC variation filings, ensuring ongoing compliance with approval conditions.
- Own labeling strategy and content development across the product lifecycle, ensuring labeling reflects agency requirements, clinical data, and commercial considerations, and is maintained in compliance with post approval obligations.
- Establish and own Loyal's regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards.
- Build and lead a high performing regulatory organization, establishing clear functional ownership across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations.
- Establish and scale regulatory governance frameworks and regulatory procedural documents - including submission templates, agency meeting management procedures, labeling review workflows, and regulatory decision documentation standards - that meet eCTD and global filing requirements and scale with the organization's growth.
- Serve as the company's independent regulatory authority, with clear accountability to escalate regulatory risks, flag compliance concerns, and advise on activities where regulatory risk warrants executive attention.
- Foster a culture of regulatory excellence and proactive risk management across the organization.
About you- 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.
Preferred Attributes- 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.
Salary Range: $280,000 - $340,000
Loyal 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
