Job Description

Role: CMC Submission Specialist

Location: Warren, NJ

We are seeking an experienced CMC Submission Specialist to support the preparation, management, and execution of Chemistry, Manufacturing, and Controls (CMC) components for an upcoming Biologics License Application (BLA). This is a hands-on regulatory operations role focused on Veeva Vault RIM/Docs and eCTD-compliant submissions aligned with FDA and ICH requirements.

The BLA submission is targeted for end of March, and this role will also support FDA information requests and follow-up activities post-submission.

Key Responsibilities

• Prepare, compile, and manage CMC sections of a Biologics License Application (BLA)
• Execute regulatory submission activities using Veeva Vault RIM/Docs
• Ensure compliance with FDA, ICH, and eCTD standards (structure, formatting, publishing)
• Coordinate with CMC, Quality, Manufacturing, and Regulatory Affairs teams to finalize submission content
• Track document readiness, manage timelines, and resolve submission issues
• Support FDA information requests, amendments, and post-submission activities
• Maintain accurate, compliant, and inspection-ready submission documentation

Required Qualifications

• Bachelor’s degree (BS) in Life Sciences or related field
• 3–5 years of experience in regulatory submissions with strong CMC focus
• Hands-on experience supporting BLA submissions
• Proficiency with Veeva Vault RIM and/or Veeva Vault Docs
• Strong knowledge of eCTD formatting and publishing requirements
• Working knowledge of FDA and ICH guidelines
• Excellent attention to detail and ability to work in fast-paced, deadline-driven environments

Preferred Qualifications

• Experience supporting biologics or biotech products
• Prior experience responding to FDA queries and post-submission requests
• Strong cross-functional communication skills

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