Regulatory Affairs Director

2 weeks ago


Germantown, Maryland, United States NSF International Full time
Job Title: Director of Regulatory Strategy

The Director of Regulatory Strategy plays a critical role in shaping and executing regulatory strategies for clinical development programs and regulatory submissions across multiple therapeutic areas at NSF International.

This leadership position requires deep knowledge of global regulatory environments, strong cross-functional collaboration, and a focus on providing expert guidance to internal teams and external clients.

Key Responsibilities:
  • Develop and execute comprehensive regulatory strategies that align with the broader business objectives of the Pharma/Biotech and Medical Devices business units.
  • Collaborate with Regulatory leadership from the NSF Life Sciences Leadership Team to drive the development and execution of strategic business plans that support product development, regulatory submissions, and market access strategies.
  • Work closely with cross-functional regulatory leaders to develop, refine, and implement strategic business plans that advance the company's objectives in the highly regulated life sciences sector.
  • Lead and oversee the implementation and optimization of the Docshop AI-driven regulatory document review, processing, and publishing process.
  • Develop strategies to integrate AI capabilities into the document review process, ensuring compliance with regulatory requirements, enhancing efficiency, and reducing submission timelines.
Requirements:
  • Strong leadership skills and a collaborative mindset.
  • Proven track record in regulatory strategy development within Pharma/Biotech and Medical Devices industries.
  • Deep understanding of the regulatory landscape and the ability to anticipate challenges.
  • Expertise in regulatory submissions, document management, and the ability to leverage advanced AI technologies to streamline regulatory workflows.


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