Regulatory Submission Manager

Location: Remote (Boston, MA preferred)

Duration: 6 months (possible extension) | Hours: EST

We are seeking an experienced Sr. Manager, Regulatory Submission Management to lead planning, execution, and tracking of complex global regulatory submissions. This role will manage submission timelines, milestones, risks, and cross-functional coordination to ensure timely and compliant filings.

Must Have Skills:

• Strong regulatory submission management and leadership experience
• Hands-on experience with Veeva Vault/RIM, Smartsheet, and Microsoft Project Online
• Solid understanding of regulatory publishing operations
• Strong project management and stakeholder communication skills

Requirements:

• 5+ years of regulatory or clinical project management experience
• Proven ability to manage multiple submissions and drive timelines
• Bachelor’s degree in Life Sciences or related field