Senior Specialist Regulatory Information Management

Regulatory Affairs Bothell, Washington


Description

Summary: 

Reporting to the head of Regulatory Information Management, the Specialist of Regulatory Information Management (RIM) provides tactical support for the implementation and maintenance of the systems, and associated processes, within Regulatory Affairs.  The primary purpose of this role will be to support the Document and Submission Management systems in general, and directly the Registration Management system and data. This would include being the general Regulatory software systems technical, validation and use expert, providing systems user training and support, planning and driving systems implementation and maintenance processes including system validation projects and other compliance efforts, systems issue identification and troubleshooting support, and ancillary software support.  This position serves as an essential partner of and support for the Regulatory Submission Management group and all the Global Regulatory Teams (GRTs), and will ensure they receive the Regulatory system and process support for the successful execution of their goals and activities.   

 

Principal Responsibilities: 

  • Good technical expertise and familiarity with the operation and use of off-the-shelf Regulatory Information Management systems relative to document, registration, and submission management, including document rendering, electronic submission publishing, dossier viewing, information management, gateways information exchanges, reporting and analytics, and product registration 
  • Good computer system validation expertise and serve as lead Regulatory system liaison with IT, IT PM, and the computer system validation technical and quality groups for all Regulatory system implementation and changes 
  • Create and manage Regulatory system change management user and compliance documentation, and provide training and support to users as required 
  • Monitor and respond to application problems using appropriate problem determination tools, track problem occurrence and resolution, and lead the escalation to IT until resolution. 
  • Collaborate with Regulatory Submission Management and all GRTs to practically understand their use of Regulatory tools, and drive process improvements where required. 
  • Becomes a liaison between GRT team members and senior management identifying and escalating system critical path issues, risks, resource needs and alternative scenarios to achieve objectives 
  • Contributes to the functional excellence of Regulatory Information Management by participation in the development and continuous improvement of processes, procedures, and tools related to program and portfolio management practices 

Qualifications:

  • At least 3-5 years of experience in Regulatory Affairs, Regulatory Operations, and/or Information Services in the pharmaceutical/biotechnology industry 

Education:

  • Bachelor’s degree, preferably in a Computer Science discipline, or related technical/scientific field, or equivalent experience 

 

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com. 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. 

#LI-TC2