Clinical Dynamix, Inc.
Vice President Regulatory Affairs
Clinical Dynamix, Inc., Cambridge, Massachusetts, us, 02140
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
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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
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