Job Description

Job Title: Technical Writer – CMC Submissions

Job Summary:

We are seeking a highly skilled Technical Writer to support Chemistry, Manufacturing, and Controls (CMC) regulatory submissions. The successful candidate will be responsible for authoring CMC content, coordinating cross-functional reviews, and leading the adjudication and finalization process to ensure delivery of high-quality, submission-ready dossiers to health authorities.

Key Responsibilities:

• Author CMC regulatory content in alignment with global submission requirements.
• Initiate and manage review cycles, ensuring timely feedback from subject matter experts and stakeholders.
• Lead comment adjudication and finalization activities to deliver accurate, compliant submission documents.
• Collaborate with cross-functional teams, including Regulatory Affairs, Quality, and Technical Operations, to gather and interpret complex scientific information.
• Ensure consistency, clarity, and compliance with regulatory and company standards across all written materials.
• Maintain awareness of current regulatory guidelines and industry best practices to support high-quality submission development.

Qualifications & Skills:

• Bachelor’s degree in life sciences, chemistry, biochemistry, or a related field (advanced degree preferred).
• Demonstrated experience in authoring regulatory documents, preferably CMC sections of health authority submissions.
• Excellent written and verbal communication skills with strong attention to detail.
• Ability to understand, analyze, and clearly present complex scientific and technical information.
• Strong organizational skills and ability to manage multiple projects under tight deadlines.
• Proficiency in Microsoft Office and document management systems; familiarity with eCTD submissions is a plus.

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