VP Regulatory Affairs - Global Strategy & Leadership

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

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