Regulatory Affairs Manager

6 days ago


Germantown, Maryland, United States Precigen, Inc Full time
About the Role

We are seeking a highly skilled Regulatory Project Manager to join our team at Precigen, Inc. in Germantown, Maryland.

This is an exciting opportunity for a motivated and organized individual to support complex filing activities, ensuring compliance with technical and regulatory standards.

The successful candidate will be responsible for developing and managing submission content plans, monitoring deliverable progress, and conducting regular project meetings with senior leadership and stakeholders.

Key responsibilities include:

  • Developing and managing submission content plans, including timelines and resources, to ensure projects are completed on time and within scope.
  • Monitoring and tracking deliverable progress, identifying potential risks, and developing mitigation strategies.
  • Conducting regular project meetings and providing updates on status, issues, and changes to senior leadership and stakeholders.
  • Ensuring regulatory reporting and documentation requirements are met, including the development of reports, presentations, and updates.

The estimated salary for this role is $110,000-$140,000 per year, based on industry standards and location.

To be successful in this role, you will need a strong knowledge-base of eCTD requirements, ICH guidelines, and FDA guidance documents, as well as experience working in global environments and interdisciplinary teams.



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