Regulatory Operations Specialist/Sr. Specialist
Responsible for the preparation of regulatory submissions in electronic Common Technical Document (eCTD) and paper format in accordance with regulatory requirements and company standards. May assist in the planning and execution of regulatory technological systems and processes.
- Tracks and compiles submission component documents from paper and/or electronic sources; 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
- Assists in the development of and implements documentation standards, templates, and procedures related to the formatting, publishing, and archiving of both electronic (eCTD) and paper submissions
- 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
- 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
- Strong communications and teamwork skills required. Attention to detail a must.
- Ability to multitask and switch gears quickly
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.