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Director, Regulatory – CMC Gene Therapy


This is a Contract position in Cambridge, MA posted May 13, 2019.

Ensure global strategies are successfully implemented and executed across our portfolios.

Interface cross-functionally with internal teams and external service providers/partners.

Demonstrate leadership and comprehensive understanding of global RA CMC regulations and guidelines to address and overcome challenges that arise during development and commercialization.

Successfully communicate and negotiate directly and indirectly with international Health Authorities as necessary.

Key Responsibilities: Develop and implement global CMC regulatory strategies for clinical and early development stage gene therapy projects.

Lead CMC regulatory activities and timelines.

Manage and implement planning, preparation and submission of high-quality CMC related applications.

Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; lead the preparation and submission of responses to CMC questions; supports interactions with regulatory agencies during GMP and pre-approval inspections.

Manage and ensure compliance with all reporting requirements.

Provide CMC regulatory guidance for global development programs.

Provide regulatory CMC support for clinic development activities.

Provide advice and carefully considered decisions regarding regulatory issues for which there may not be clear/specific regulatory guidance or precedence.


Category: Science, Keywords: CMC Director0