Seattle Genetics
Manager, Regulatory Information
Regulatory Affairs - Bothell, Washington
Description
Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.
Summary:
The Manager of Regulatory Information implements, configures, and maintains the Regulatory Information Management System (RIMS). Within RIMS, inputs, archives and retrieves regulatory documentation and commitments, with input from regulatory colleagues. Coordinates with IT and Regulatory Operations on system updates. Responsible for ensuring applicable personnel are trained on the RIMS and all system updates.
Responsibilities:
- Manages the implementation, upgrades, and maintenance of the Regulatory Information Management System (RIMS) for efficient electronic management of regulatory information.
- Configures RIMS for ease of submission planning, viewing, reporting, archival and retrieval that supports the lifecycle of all products.
- Coordinates regulatory documentation and uses RIMS to track, archive and retrieve all regulatory information, including submissions to health authorities, correspondence, questions, and commitments.
- Enters records in RIMS for all submission-related correspondence and commitments to regulatory agencies; develop as automated an entry process as possible.
- Generates reports for functions outside Regulatory with a need to know.
- Maintains RIMS documentation and generates SOPs and Work Practices for RIM/RIMS.
- Represents Regulatory Information Management on electronic technical matters to IT, Clinical Systems, and RIMS vendor(s).
- Responsible for training all regulatory colleagues on use or changes to RIMS.
Qualifications:
- Bachelor’s degree in related field.
- At least 3 years experience working in Regulatory in the drug/biologic development industry, with knowledge of fundamental regulatory reporting requirements.
- Proven experience using a document management system and/or Regulatory Information Management System (RIMS).
- Experience with eCTD submission publishing and submission management a plus.
- Demonstrated proficiency using Microsoft Office Suite, Adobe Acrobat, and document templates.
- Experience in system validation is desirable.
- Excellent attention to detail, with experience reviewing documents.
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegentics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Apply:
Seattle Genetics
Seattle Genetics is an Equal Opportunity Employer
Submitted: 04/13/2018
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