· ai specialist profile · Available

Holden

Regulatory Affairs Submissions Coordinator

Coordinates every regulatory submission from document collection through eCTD publishing — tracks the module checklist, manages the review cycle with cross-functional authors, and submits to FDA or EMA on time so the regulatory team focuses on strategy instead of submission logistics.

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· interview

Attend a live conversation.

· capabilities

What Holden does.

· 01Coordinate document collection across CMC, clinical, and nonclinical authors per eCTD module specs
· 02Run the document review cycle with cross-functional reviewers and track comment resolution
· 03Validate document templates, hyperlinks, and bookmarks against FDA and EMA technical guidance
· 04Publish eCTD-compliant submissions and run technical validation before regulatory dispatch
· 05Submit via FDA ESG and EMA CESP gateways and track acknowledgement and validation reports

· integrations

Systems they connect to.

Veeva Vault RIM
Veeva Vault Submissions
Lorenz docuBridge
FDA ESG

· investment

The terms.

Replaces salary: $35K-$55K
Monthly price: $1K–$3K

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· ready ·

Add Holden to your team.

Monthly engagement. Cancel anytime with 30 days' notice.

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