Project Management Specialist

6 days ago


Germantown, Maryland, United States Precigen, Inc Full time
Job Description

Precigen, Inc. is seeking a Regulatory Project Manager to support our Regulatory Affairs team in Germantown, Maryland.

The successful candidate will be responsible for supporting complex filing activities, ensuring compliance with technical and regulatory standards, and coordinating submission planning and timelines with internal publishers and external vendors.

Key responsibilities include:

  • Managing regulatory submission documentation, including regulatory authority correspondence, in an electronic document management system (EDMS) or hardcopy archive location.
  • Providing input to project and product regulatory strategy based on international regulatory requirements and supporting international regulatory submissions by providing needed data and documents.
  • Contribute as needed to answer Health Authority questions on submissions and track commitments to Health Authorities.

The estimated salary for this role is $120,000-$150,000 per year, based on industry standards and location.

To be successful in this role, you will need a minimum of 5 years of experience in pharma/biopharma/contract research organization (CRO) regulatory, with a minimum of 2 years of Regulatory Project Management experience.



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