Technical Writer – CMC Submissions

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 :