Loyal - Vice President, CMC 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 CMC regulatory strategy across all active programs, aligned with development milestones and commercial objectives, from early development through approval and post approval lifecycle management. • Provide CMC 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 strategies. • Provide regular CMC 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. • Own the CMC technical section 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 on CMC matters, 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. • Establish and own Loyal's regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards. • Build and lead a high performing CMC regulatory organization, establishing clear functional ownership. • 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 CMC 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.