Related skills
sharepoint veeva rim ind ctas📋 Description
- Data steward of regulatory data in RIM; enter, update, and maintain records.
- Create, archive, and maintain regulatory submissions and Health Authority docs in RIM.
- Maintain submission trackers, timelines, and history for Health Authority commitments.
- Coordinate with cross-functional teams to support US submission planning and delivery.
- Support prep and organization of INDs, CTAs, and amendments.
- Perform QC activities, including eCTD QC for US submissions, to ensure readiness.
🎯 Requirements
- BS (or equivalent) in related scientific discipline
- 2+ years of pharma/biotech regulatory affairs experience (preferred)
- Strong organizational skills and attention to detail
- Strong written and verbal communication; ability to collaborate with stakeholders
- Proficiency in MS Word, Excel, PowerPoint; SharePoint/Teams preferred
- Experience with Veeva RIM and eCTD submissions (preferred)
🎁 Benefits
- Culture grounded in CORE values: Caring, Original, Resilient and Egoless
- Fast-paced environment with opportunities to shape culture and growth
- Market-competitive compensation and equity opportunities
- Generous PTO, two company shutdowns, and paid sick leave
- Commitment to professional growth with development resources
- Regular all-team in-person meetings to build relationships
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