Job Title: Senior Pharma Submission SME with Veeva RIMS
Location: Must be local to Bay area, CA
Job Requirements:
• 10+ years of experience in regulatory affairs, operations, or technical writing with strong business background within the biotech or pharmaceutical industry
• Strong experience with Veeva RIMS
• Expertise in regulatory submissions including INDs, NDAs, BLAs, eCTD, and global health authority requirements
• Ability to translate complex technical, clinical, and CMC content into compliant submission formats
• Experience leading submission strategy, process development for authorship, technology leadership, template standardization, process optimization, and audit/compliance support
• Strong collaboration skills across scientific, regulatory, and publishing teams.
**These individuals should be seasoned consultants with strong communication, client engagement, and leadership capabilities, along with deep technical expertise in their respective domains, to be a face of our client in their respective area. The selected resources will work closely with our client leadership to help develop opportunities with the client by providing architectural vision, roadmaps, and solution guidance. They must be able to establish and maintain strong professional relationships with the client's leadership team, product owners and stakeholders, and effectively engage with senior business and technology leaders.
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