Vice President Regulatory Affairs

Clinical Dynamix, Inc.; Cambridge (MA); Presencial; USD 250.000 - 380.000; Jornada completa

Descripción de la vacante

Clinical Dynamix, Inc. in Cambridge, MA is seeking a Vice President of Regulatory Affairs to lead the company's regulatory strategy and capabilities.

The VP will report to the CMO and partner with executive, program management, and quality teams to navigate FDA/EMA requirements and drive development toward regulatory approval for our stem cell therapies. You will oversee global submissions (FDA/EMA), direct in-house regulatory talent, manage budgets and vendors, and guide due diligence for

Formación

• 15+ years in pharma/biotech across product lifecycle.
• 4+ years in Cell Therapy with IND/NDA submissions and FDA/EMA interactions.
• BS in life sciences; advanced degree or certification preferred.
• Deep knowledge of FDA/EMA regulations and guidance.
• Experience with eCTD regulatory filings.
• Global regulatory experience with US/EU/Japan authorities.
• Strong leadership and cross-functional collaboration.
• Hands-on, pragmatic problem-solver in fast-paced teams.

Responsabilidades

• Develop and lead the global regulatory strategy for the company.
• Build in-house regulatory capabilities aligned to needs.
• Provide strategic guidance on regulatory submissions.
• Determine regulatory partnering and outsourcing strategy.
• Lead regulatory submissions for FDA, EMA, and others.
• Ensure compliance with regulatory standards and guidance.
• Drive communications with health authorities and inspections.
• Liaise on regulatory matters with QA and site teams.
• Oversee regulatory document processes and product files.
• Support due diligence for in-licensing and collaborations.
• Manage regulatory budgets and vendors; stay current on regs.
• Occasional travel to Boston and other sites.

Conocimientos

Regulatory leadership

IND/NDA submissions

FDA/EMA interactions

eCTD submissions

Regulatory strategy

Budget & vendor management

Cross-functional leadership

Global regulatory knowledge

People management

Problem solving

Educación

BS in Life Sciences

Advanced degree

Professional certification

Herramientas

Regulatory submissions software

Quality systems understanding

Descripción del empleo

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