Vice President OF Regulatory Affairs

Vice President, Head of Regulatory StrategyScholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. The Vice President, Head of Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is accountable for building and leading the Global Regulatory Strategy team, responsible for the development of global regulatory strategy across the portfolio. As a subject matter expert, this individual will represent regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan. The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission of regulatory submissions.Position ResponsibilitiesServe as a thought leader on regulatory affairs, defining global regulatory strategy and plan to maximize regulatory success across the portfolio.Serve as the global regulatory lead, providing strategic and operational input on assigned clinical and/or pipeline programs, such as the subcutaneous (IV to SC) and OPAL (<2 years old) program teams to achieve program objectives while ensuring compliance with applicable regulatory requirements in the region.Be responsible for leading the global supplemental/type 2 variation filing lead for OPAL (<2 years old)Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement planLead and managing regulatory interactions on assigned programs, building trusted relationships with regulatory authoritiesLead cross-functional effort to ensure timely submission of key regulatory documentEnsure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory successIdentify regulatory risks and opportunities and work with key stakeholders to develop solutionsPartner with global market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicablePartner with Global and local Marketing/ Commercial as needed to align Regulatory Plan and Marketing/Commercial planEnsure strong representation of regulatory voice at key governance bodies and teams (e.g., DRC, program teams, clinical development teams, study teams)Maintain currency of regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure complianceMonitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure complianceProvide support to local regulatory expertsProvide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as neededCandidate RequirementsEducation in life sciences requiredGreater Boston-based with ability to be regularly present in the Cambridge, MA office15+ years of experience Regulatory Affairs in biopharmaceutical industry with deep understanding of US/EU regulatory requirementsDemonstrated experience of leading successful engagement with FDA and EMAExpertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred but not requiredDemonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skillsStrong written, verbal communication skills, and interpersonal skillsCapable of managing shifting priorities in a rapidly changing and environmentAbility to travel domestically and internationally (~20%)$305,000 - $360,000 a yearScholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.