Vice President Regulatory Affairs

Vice President, Regulatory AffairsThis 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 companyBuild 'fit to needs' essential in-house regulatory capabilitiesProvide strategic and technical guidance on regulatory submissionsDetermine the Regulatory partnering and outsourcing strategyLead the development of regulatory submissions for FDA, EMA, and other health authoritiesEnsure compliance with applicable standards, Regulatory regulations and guidance, and associated requirements for pharmaceutical developmentProactively drive communications with health authoritiesIn partnership with the head of Quality, serve as the primary regulatory liaison for site inspections, presentations, submissions, and compliance mattersGuide the establishment of procedures and processes that ensure regulatory document complianceOversee Regulatory Affairs product files to support compliance with all regulatory requirementsProvide 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 vendorsMaintain knowledge of regulatory requirements and trends up to current dateOccasional travel to the Boston office and other locations as requiredQualifications include:Passionate about our mission to transform the lives of patients who require transplantsExtensive drug development leadership experience in biotech / biopharmaceutical R&D across all stages of the product lifecycleBS or equivalent degree in life sciences required. Advanced degree and/or professional certification preferred15+ 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 developmentIn depth knowledge of current FDA and EMA regulations and guidance documentsExperience in hematology and/or immunology is considered a plusGlobal experience with prior success interacting with US, EU, and/or Japanese regulatory authorities requiredAccomplished leader and manager, ideally having effectively managed regulatory affairs across emerging and larger companiesExtensive knowledge of U.S. and International regulations including cGMP, GCP, GLP, ICHExperience managing consultants and contractors and ensuring the integrity and timeliness of their workExtensive knowledge and experience with eCTD regulatory filings/ electronic submissionsStrong understanding of drug development R&D, manufacturing, laboratory, and Quality systemsStrong people management, collaboration and influencing skillsPragmatic thinker and problem-solverThrive in a fast-paced, changing team environment and willing to be hands-on