Executive Director - International Regulatory Affairs

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 Senior Vice President, Global Regulatory Affairs, the Executive Director, International Regulatory Affairs will lead the development and execution of regulatory strategy across Europe and Rest of World (ROW) markets, translating corporate and portfolio priorities into coordinated regulatory plans that enable development and commercialization objectives.

This individual will partner with the Global Regulatory Lead on the development and execution of international regulatory strategies across all stages of product development and commercialization, ensuring alignment with corporate objectives and global regulatory requirements.

The position requires deep expertise in European regulatory procedures, extensive experience interacting with international health authorities, and demonstrated leadership in developing innovative regulatory strategies for biologics and other pharmaceutical products.

In close collaboration with cross-functional partners, the Executive Director integrates scientific, non-clinical, clinical, regulatory and business insights to guide and support the development of critical programs. The role ensures that development strategies are aligned with regulatory expectations and are designed to achieve successful outcomes in target global markets.

This role may be located in the United States or the United Kingdom. For remote employees, travel to US headquarters for meetings may be required at the discretion of management. For those local to Waltham, MA, our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Develop and execute international regulatory strategies for assigned programs, ensuring alignment with overall global development and commercialization objectives
• Serve as the strategic partner for regulatory activities in Europe and other international markets
• Provide expert guidance on regional regulatory requirements, precedents, and emerging regulatory trends
• Identify regulatory risks and opportunities and develop effective mitigation and acceleration strategies
• Oversee interactions with international health authorities, including EMA, national competent authorities, MHRA, Swissmedic, PMDA, NMPA, Health Canada, TGA, and other agencies as appropriate
• Develop regulatory engagement strategies and oversee preparation of briefing materials and meeting packages
• Facilitate agency review activities and coordinate responses to regulatory questions and requests
• Provide regulatory leadership for preparation and execution of CTAs, Scientific Advice procedures, Pediatric Investigation Plans (PIPs), Marketing Authorization Applications (MAAs), and post-approval submissions
• Ensure high-quality, compliant, and timely regulatory submissions across international markets.
• Oversee preparation of regulatory documentation supporting development and commercialization activities
• Ensure consistency and alignment between regional and global regulatory submissions
• Collaborate with multidisciplinary teams, driving alignment among Clinical Development, Safety, Biostatistics, Medical Writing, Quality, and Commercial teams
• Communicate international regulatory strategy, risks, and milestones to senior management and key stakeholders
• Support portfolio planning and governance decisions through strategic regulatory input
• Partner closely with International Market Access to align regulatory and reimbursement strategies
• Collaborate effectively with alliance partners, consultants, and regional affiliates
• Monitor evolving international regulatory requirements, guidance documents, and regulatory initiatives
• Assess the impact of regulatory developments on company programs and recommend appropriate actions
• Provide thought leadership regarding international regulatory strategy and policy
• Contribute to company regulatory processes, standards, and best practices

Qualifications:

• Bachelor’s degree (or equivalent) in a science field such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferred
• Minimum of 15+ years of increasing responsibility in Regulatory Affairs within the biopharmaceutical industry, or 12+ years of experience plus an advanced degree (e.g., PhD, PharmD, JD)
• Significant experience leading international regulatory strategy for biologics and/or innovative therapeutics
• Demonstrated experience leading global teams through CTIS regulatory activities, including initial clinical trial applications, non-/substantial modifications, Investigational Medicinal Product Dossier updates, and regulatory interactions across EU Member States
• Demonstrated success obtaining approvals in Europe and major international markets
• Extensive experience with European regulatory procedures, including MAA submissions and EMA interactions
• Proven track record leading regulatory activities across multiple stages of development through commercialization
• Experience managing complex global regulatory programs and cross-functional teams
• Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies
• Strong oral and written communication, time management, and team-oriented leadership skills are essential
• Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
• Proven mindset of proactive continuous improvement
• Strong attention to detail
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 25%
• The salary range for this position is commensurate with experience