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