Director Regulatory Operations

4 days ago

Boston, United States EPM Scientific Full time

Title: Director, Regulatory Operations


A growing biotechnology company is seeking a Director of Regulatory Operations to lead and manage the regulatory strategy and operations for global submissions and systems projects in a dynamic, rapidly evolving environment. This organization is focused on developing innovative therapies for rare and underserved diseases, leveraging cutting-edge science to target key biological pathways for genetic conditions. The Director will be responsible for providing leadership in regulatory operations, ensuring efficient submission processes and compliance, while fostering collaboration across cross-functional teams.


Responsibilities

  • Provide regulatory operations expertise and leadership to cross-functional teams supporting the pipeline, training and leading regulatory operations personnel reporting into this role.
  • Lead the development, refinement, and implementation of internal processes, procedures, work instructions, and training programs for submission production and operational support activities. As needed, train colleagues and project teams.
  • Oversee the full implementation, maintenance, and optimization of a Regulatory Information Management (RIM) system.
  • Provide RIM system leadership by overseeing the development of RIM projects based on current and future business needs, optimizing the use of system attributes.
  • Oversee and manage all global regulatory submissions, systems-related projects, and submission compliance.
  • Oversee the management of external publishing vendors.
  • Ensure proper maintenance of regulatory submissions filing, Health Authority correspondence logs, and archival of previous regulatory submissions.
  • Oversee the build of submission binders and content plans for future global regulatory submissions.
  • Stay current with regulatory requirements and industry best practices.
  • Prepare and present regulatory reports, metrics, and dashboards.
  • Lead budgeting and forecasting activities for the Global Regulatory Operations function, including managing vendors.


Requirements

  • Bachelor’s Degree in life sciences or a related field.
  • 8+ years of Regulatory Operations experience in the pharmaceutical/biotech industry.
  • NDA/MAA filing experience.
  • Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing and electronic document management systems.
  • Understanding of drug development and business processes.
  • Knowledge and experience with eCTD submissions.
  • Knowledge of FDA, EMA, and ICH guidelines.
  • Proven internal and external leadership with the ability to work cross-functionally and globally.
  • Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.
  • Extensive knowledge in the implementation of GxP Systems (e.g., Document Management Systems) and formatting solutions (e.g., authoring templates).
  • Comfortable in a small company environment that is fast-paced, challenging, and requires a hands-on approach to achieving results.

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