Job Title: Regulatory Affairs Associate - I
Location: Seattle, WA 98102
Description: **This is an Entry Level Position with relevant experience in Pharma Development preferred**
Specific Responsibilities: Will interact with management and team members to perform submission, and electronic publishing activities associated with generating hard copy and electronic submissions in accordance with global regulatory guidelines. Must have a strong working knowledge of MS Word, Adobe Acrobat and standard Office tools. Experience with ISIToolbox, Docubridge, Insight Publisher, or other eCTD preparation tools is a plus. The ideal candidate will have experience working in the life sciences, including work with electronic document management systems, global regulatory submissions, or other experience directly related to Regulatory Operations. eCTD regulatory publishing experience is a plus. Essential Duties and Job Functions: As a member of the Regulatory Operations team, this position prepares and completes a variety of moderately complex submission compilation activities including utilization of publishing tools for electronic and paper submission generation, scanning, QA/QC, and electronic and paper archival in partnership with Central Records.
- Generates routine hard copy and electronic submissions using publishing systems that generate XML based eCTD submissions.
- Conducts quality checks of documents to ensure they meet with global regulatory standards prior to inclusion into regulatory submissions.
- Conducts quality checks of own work to ensure adherence with company's high standards as well as global regulatory standards.
- Participates in supporting and promoting current electronic initiatives in moving the company forward with electronic submissions and electronic archives.
- Participates in the development or upgrading of publishing process as well as work instructions that relate to submission standards, content and processes.
- Will interface with project managers, regulatory product managers, and or content authors to provide guidance on submission preparation and content.
- In addition to submission compilation activities, and may assist with the development and management of projects as applicable in support of the Regulatory Operations department. Maintains constructive and positive interactions with colleagues.
Knowledge, Experience and Skills:
- Typically requires a BA/BS with 2+ years of relevant experience or an MS with 1+ years of relevant experience.
- Experience in document management and Regulatory publishing as applicable is a plus.
- Familiarity with pharmaceutical development and Regulatory global submissions is a plus.
- Must have excellent verbal and written skills, strong organizational and time management skills and strong attention to detail.
- Must be able to balance multiple tasks simultaneously to achieve goals and satisfy customers.
- Works under limited direction and may independently determine and develop approaches to non-routine problems.
- Must possess flexibility to work effectively within an environment that has quickly changing processes, priorities and deadlines.
Sthree US is acting as an Employment Business in relation to this vacancy.