Director, Regulatory Operations

Location
Bothell, Washington
Posted
Apr 02, 2018
Ref
2FoX6Z6fwS
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Provides strategic and tactical leadership to the Regulatory Operations group in support of making electronic submissions to FDA, Health Canada and eventually EMA.  Maintains a searchable and retrievable archive of all submissions and correspondence with regulatory authorities.  Hires and builds the group as needed, within the budget. Is a direct collaborator with IT and Clinical Systems.  Contributes to the operational decisions for the department as a member of the Regulatory Affairs Leadership Team.

 Responsibilities: 

  • Manages direct reports to assure time-sensitive submissions are delivered in a manner that meet the submission specifications of regulatory authorities. Submissions include original BLA/NDSs and INDs, supplements and amendments to these original documents, promotional materials to FDA OPDP, and Structured Product Labeling in the US. In time, will include MAAs to EMA
  • Assures Seattle Genetics is in compliance with electronic submission requirements and appropriately anticipates changes to remain in compliance
  • Leads the evaluation of appropriate software and upgrades for submissions and archival, and develops the capacity for electronic submission of promotional materials to FDA
  • Manages and maintains the archive of submissions, correspondence, commitments etc. made to regulatory authorities that is complete, and searchable and retrievable by multiple users within Regulatory Affairs
  • Determines best utility for the Enterprise Content Management System for all users within Regulatory and builds and maintains the system accordingly
  • Be an active member of Regulatory Affairs Leadership Team, interacting to represent the needs of Regulatory Operations in the context of the broader departmental needs
  • Represents Regulatory Affairs on electronic technical matters to IT and Clinical Systems
  • Responsible for hiring, managing and coaching direct reports to build capacity for anticipated original BLA and MAA submissions

Qualifications: 

  • BA/BS preferably in a scientific discipline with 10+ years of experience in the biotechnology or pharmaceutical industry, including at least 5 years in regulatory operations
  • Expertise in document publishing processes, electronic submissions of BLA/NDA/INDs and eCTD-related software required
  • Thorough knowledge of US, Canadian and European submission specifications
  • Expertise in archival and retrieval systems for regulatory submissions and communications
  • Demonstrated ability to evaluate and select submission and archival software
  • Detail-oriented, with strong communication skills with other regulatory affairs professionals and IT colleagues
  • Strong skills in people management required

 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.