Director/ Senior Director, Regulatory CMC

requirements to ensure all development activities follow applicable regulations and guidelines. · Provide regulatory strategic and tactical support for CMC aspects such as change control & inspection management. Assess proposed manufacturing process changes, provide expertise on raw materials management, DP/DS specifications and release, process characterization & validation, methods development & validation and provide strategic regulatory guidance to enable implementation. · Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance and integrate into program plans. · Maintain responsibility for all CMC Regulatory timelines, that also includes managing contract staff and vendors relevant to CMC activities. · Build and maintain strong relationships with internal and external stakeholders. Skills and

requirements: · PharmD or PhD preferred with ≥8 years of industry experience in Regulatory CMC biologics. Strong scientific background and training in manufacturing processes and development and development of combination biologic/device products are required. Small molecule and medical device experience are a plus. Experience working with FDA sCDER is required. · A strong background & track record in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of biologic medicinal products. · A broad understanding of all aspects of CMC including process development, regulatory and quality

requirements, analytical development, formulation and drug product technologies, distribution in US/ex-US. · Experience interfacing with FDA, and other global health authorities. · Demonstrated risk identification and critical thinking skills. · Strong understanding of the global pharmaceutical drug development and regulatory environment, including anticipating future trends and opportunities in biologics. · Ability to interact effectively across all levels of the organizations; integrates functional expertise with business knowledge to solve problems, meet priorities and deadlines in alignment with corporate goals and objectives. · Recognized as an influential leader who possesses a cross-functional collaborative skill set. · Strong oral and written communication skills with strong attention to detail and the ability to coordinate multiple activities in a faced paced biotech environment. · Able and willing to author regulatory documents as needed and provide guidance to subject matter experts on authoring regulatory appropriate CMC reports and assessments. The salary range for the Director, Regulatory CMC is expected to be between $200,000 and $220,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location. The salary range for the Senior Director, Regulatory CMC is expected to be between $250,000 and $265,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location. At Vor, we support our team with robust

benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information.

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