Regulatory Operations and Publishing Sr. Associate, Apply
Job Responsibilities:
- Independently prepare and submit eCTD and non-eCTD submissions of varying complexity to IND/CTA and NDA/MAA applications
- Format MS Word and Adobe Acrobat files to a state of submission-readiness
- Act as department liaison to publishing and archival vendors
- Provide support to Regulatory Affairs in the creation of submissions documents
- Manage and maintain correspondence and other records in regulatory tracking system
- Coordinate the exchange of records using document-sharing platforms
- Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommend and help implement process improvements
Primary Job Requirements:
- Bachelor's degree or equivalent experience
- 3 to 5 years of relevant Regulatory Operations experience in biotech/pharmaceutical industry
- Strong understanding of submission requirements
- Records management concepts, and electronic tools and systems.
- Expert-level document formatting and submission building (eCTD and non-eCTD)
- Expert-level knowledge of PDF Publishing tool (ToolBox preferred)
- Proficiency in Microsoft Word, Microsoft Excel,
- Acrobat Professional, and Sharepoint
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Excellent organization, written/verbal communication, and attention to detail
Preferred Experience:
- Grouped and OPDP Submission experience
- ToolBox
- Acuta PDF
- Extedo eCTDManager
- Veeva Vault
- Veeva RIMS
