Director Regulatory Affairs

The Director of Regulatory Strategy is responsible for shaping and executing regulatory strategies for clinical development programs and regulatory submissions across multiple therapeutic areas. This leadership role requires deep knowledge of global regulatory environments, strong cross-functional collaboration, and a focus on providing expert guidance to internal teams and external clients. The role plays a critical role in the planning and delivery of regulatory services, from preclinical development through marketing authorization.

The Director of Regulatory Strategy will lead and oversee the implementation and optimization of the Docshop AI-driven regulatory document review, processing, and publishing process. This role requires expertise in regulatory submissions, document management, and the ability to leverage advanced AI technologies to streamline regulatory workflows. The Director will be responsible for developing strategies to integrate AI capabilities into the document review process, ensuring compliance with regulatory requirements, enhancing efficiency, and reducing submission timelines. Key responsibilities include guiding the automation of document formatting, ensuring the accuracy of regulatory content, managing regulatory submissions, and collaborating with cross-functional teams to maintain high-quality standards. This position is ideal for a proactive leader who can navigate the evolving regulatory landscape and drive innovative AI solutions for regulatory document management.

The Director of Regulatory Strategy will play a pivotal role in collaborating with Regulatory leadership from the NSF Life Sciences Leadership Team across Pharma/Biotech and Medical Devices business units. This position is responsible for driving the development and execution of comprehensive regulatory strategies that align with the broader business objectives of these units. The Director will work closely with cross-functional regulatory leaders to develop, refine, and implement strategic business plans that support product development, regulatory submissions, and market access strategies. This role requires a deep understanding of the regulatory landscape, the ability to anticipate challenges, and the expertise to integrate insights from multiple business units to create unified strategies that advance the company's objectives in the highly regulated life sciences sector. The ideal candidate will possess strong leadership skills, a collaborative mindset, and a proven track record in regulatory strategy development within Pharma/Biotech and Medical Devices industries.