CMC Writer - Regulatory Affairs

AL Solutions; United States; Remote; USD 60,000 - 142,000; Full time

Job summary

AL Solutions is seeking an experienced CMC Writer for a fully remote contract. In this role, you'll draft and finalize BLA submissions, collaborating with regulatory and technical teams. Ideal candidates will have significant experience in regulatory writing with knowledge of FDA requirements and CMC processes.

Benefits

Flexible, remote work arrangements

Competitive hourly rate

Potential for long-term collaboration

Qualifications

• Minimum 5 years of experience in regulatory medical writing.
• Strong focus on CMC for biologics with a proven track record in BLA submissions.
• Solid understanding of FDA requirements and biopharmaceutical manufacturing.

Responsibilities

• Draft and finalize CMC sections for BLA submissions in line with FDA guidelines.
• Collaborate with technical teams and ensure documents meet submission standards.
• Translate scientific data into compliant submission content.

Skills

Regulatory Writing

Collaboration

Communication

Job description

Direct message the job poster from AL Solutions

Expert in connecting top Regulatory Affairs & C-suite talent with Biotech, CRO, and Pharmaceutical clients across Europe and the US.

About the Opportunity

Our client, a growing regulatory affairs consultancy supporting biopharma companies across the US and EU, is seeking an experienced CMC Writer to support the preparation of BLA submissions. This is a fully remote, flexible contract ideal for a highly skilled writer who thrives in a hands-on, collaborative, and fast-moving consultancy environment.

Key Responsibilities

• Draft, review, and finalize high-quality CMC sections (Module 3) of BLA submissions in alignment with FDA requirements and ICH guidelines
• Collaborate closely with internal consultants and client technical teams (e.g., Regulatory, CMC, QA, and Manufacturing)
• Translate complex scientific and technical data into clear, compliant, and structured submission content
• Ensure documents are submission-ready and aligned with strategic regulatory messaging
• Contribute to responses to FDA questions related to CMC content, as needed

Requirements

• Minimum 5 years of experience in regulatory medical writing, with a strong focus on CMC for biologics
• Proven track record of authoring Module 3 sections for BLA or similar regulatory submissions (IND, MAA, etc.)
• Solid understanding of FDA regulatory requirements, ICH guidelines, and biopharmaceutical manufacturing processes
• Strong collaboration and communication skills—comfortable working with cross-functional and external stakeholders
• Ability to work independently with minimal oversight in a deadline-driven environment

Nice to Have

• Previous experience in a consultancy or contract setting
• Background in cell/gene therapy, monoclonal antibodies, or other complex biologics
• Familiarity with eCTD structure and publishing requirements

What We Offer

• Flexible, remote contract opportunity
• The chance to work with a specialized regulatory consultancy on innovative, science-driven projects
• Competitive hourly rate and potential for long-term collaboration

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Writing/Editing, and Science

• Industries

  Research Services, Biotechnology Research, and Pharmaceutical Manufacturing

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