Vice President Regulatory Affairs

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