Regulatory Operations Specialist/Sr. Specialist

Location
Bothell, WA, United States
Posted
Jul 23, 2018
Ref
21-oYrh7fwx
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Summary:

Lead efforts in transition of paper-based promotional materials to new electronic standards. Responsible for the preparation of regulatory submissions of promotional materials in electronic Common Technical Document (eCTD) and paper format in accordance with regulatory requirements and industry standards. Assist in other regulatory submissions of electronic documents to all active applications. May assist in the planning and execution of regulatory technological systems and processes.

Responsibilities:
  • Lead submission of promotional materials to FDA OPDP in compliance with current electronic requirements
  • Assists in the development of and implements documentation standards, procedures, and timelines related to the formatting, publishing, and archiving of OPDP submissions
  • Tracks and compiles other submission documents from paper and/or electronic sources for all active programs; edits, formats, assembles, and publishes submission documents in accordance with established timelines
  • Ensures completion of high-quality submissions in electronic (eCTD) and paper format for compliance with all applicable regulations, guidances, and Regulatory Operations document specifications
  • Assists submission authors and regulatory liaisons in the planning and preparation of regulatory submissions; when appropriate, composes regulatory forms, correspondence, and text
  • Retrieves archived regulatory documents (both paper and electronic) as necessary
  • May participate on project teams as appropriate for assigned projects and/or submissions
  • May assist in the evaluation, implementation, testing, and administration of Regulatory systems, including databases, documentation management systems, and publishing technologies for regulatory submissions


Qualifications:
    • Bachelor's degree or equivalent experience, preferably in a scientific discipline
    • 1-5+ years of experience in Regulatory Affairs/Regulatory Operations in the pharmaceutical/biotechnology industry
    • Proficiency in Microsoft Office and Adobe Acrobat software required
    • Proficiency in eCTD format and FDA submission requirements
    • Experience with eCTD publishing software preferable
    • Familiarity with technologies (e.g., eCTD systems, ESG, XML) to support electronic submissions and labeling preferable
    • Familiarity with Regulatory Ad Promo preferable
    • Strong communications and teamwork skills required. Attention to detail a must
    • Ability to multitask and switch gears quickly


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.seattlegenetics.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.