Viridian Therapeutics

Lead CMC regulatory activities supporting product development and liaise with health authorities. | Senior-level experience in regulatory affairs, strong understanding of global CMC regulations, and experience with regulatory submissions. | At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the Vice President, Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities that support the company’s product development strategies and providing guidance to broader CMC functions. This individual will ensure all applicable CMC regulatory requirements are considered and appropriately incorporated into clinical and commercial product development plans. The incumbent will work collaboratively with senior leadership and key stakeholders to develop CMC regulatory objectives for one or more programs, lead the preparation and filing of regulatory CMC submissions, and manage the preparation for interactions with Health Authorities. This role may be fully remote or based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week. Travel to headquarters for meetings may be required at the discretion of management. Responsibilities (including, but not limited to): • Lead the development of CMC regulatory strategy for assigned clinical-stage programs, identifying key issues, necessary remediation activities, and opportunities for acceleration throughout project/product life cycle • Assess and communicate CMC regulatory requirements to ensure all global development activities comply with applicable regulations and guidelines in each jurisdiction • Lead and facilitate the preparation for CMC-focused meetings with FDA, EMA, or national competent authorities, and participate in or lead the interactions with these agencies • Serve as the regulatory representative at internal CMC team meetings • Work within a cross-functional team to coordinate and prepare high quality, timely correspondence and CMC regulatory submissions (e.g., original INDs, CMC amendments, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development • Provide regulatory review and input on core product development documentation (e.g., stability protocols and reports, method or process validation protocols and reports, specifications, technical assessments, etc.) • Lead and coordinate with appropriate team members and stakeholders to resolve outstanding CMC regulatory issues • Work directly with external contractors and collaborators, managing the chain of communication and updating regulatory project plans as necessary for accuracy and success • Coordinate and conduct CMC regulatory project review sessions, determine frequency and content of status reports, and deliver routine updates including presentations to Regulatory department, Product Development Team Lead, or executive management, as required • Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities • Provide input on project related budgets and ensure projects operate within capital and expense budget guidelines