Clinical Dynamix

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POSITION SUMMARY Position Title: Vice President, Regulatory Affairs Reports to: CMO Company Summary: Client is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells. We have breakthrough potential to provide patients with rapid and broad access to HLA-compatible transgene-free blood stem cell therapies. Client is committed to advancing science and enhancing the health and well-being of patients. This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform. Position Summary: This is a newly created full-time position to continue the development and lead Client's Regulatory Affairs capabilities. The Vice President of Regulatory Affairs will be a member of the Leadership Team and work closely with the various members of Executive Leadership, Program Management, Technical Operations, and Nonclinical Development. The VP of Regulatory Affairs serves as a strategic partner for all functional areas in the company. Regulatory Affairs recommends development phase-appropriate strategies and tasks to guide development in compliance with regulation and regulatory guidance to maximize efficient and successfully leading to regulatory approval for the company’s off-the-shelf stem cell technology. Specific responsibilities include, but are not limited to: • Develop and lead the global regulatory strategy for the company • Build ‘fit to needs’ essential in-house regulatory capabilities • Provide strategic and technical guidance on regulatory submissions • Determine the Regulatory partnering and outsourcing strategy • Lead the development of regulatory submissions for FDA, EMA, and other health authorities • Ensure compliance with applicable standards, Regulatory regulations and guidance, and associated requirements for pharmaceutical development • Proactively drive communications with health authorities • In partnership with the head of Quality, serve as the primary regulatory liaison for site inspections, presentations, submissions, and compliance matters • Guide the establishment of procedures and processes that ensure regulatory document compliance • Oversee Regulatory Affairs product files to support compliance with all regulatory requirements • Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions. • Manage regulatory budgets and vendors • Maintain knowledge of regulatory requirements and trends up to current date • Occasional travel to the Boston office and other locations as required Qualifications include: • Passionate about our mission to transform the lives of patients who require transplants • Extensive drug development leadership experience in biotech / biopharmaceutical R&D across all stages of the product lifecycle • BS or equivalent degree in life sciences required. Advanced degree and/or professional certification preferred • 15+ years in the pharmaceutical or biotech industry, 4+ years in Cell Therapy with direct regulatory experience with IND and NDA submissions and FDA/EMA interactions for drugs in development • In depth knowledge of current FDA and EMA regulations and guidance documents • Experience in hematology and/or immunology is considered a plus • Global experience with prior success interacting with US, EU, and/or Japanese regulatory authorities required • Accomplished leader and manager, ideally having effectively managed regulatory affairs across emerging and larger companies • Extensive knowledge of U.S. and International regulations including cGMP, GCP, GLP, ICH • Experience managing consultants and contractors and ensuring the integrity and timeliness of their work • Extensive knowledge and experience with eCTD regulatory filings/ electronic submissions • Strong understanding of drug development R&D, manufacturing, laboratory, and Quality systems • Strong people management, collaboration and influencing skills • Pragmatic thinker and problem-solver • Thrive in a fast-paced, changing team environment and willing to be hands-on