Loyal - VP of Regulatory Affairs

• 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.