Note: The job is a remote job and is open to candidates in USA. Employvision Inc. is hiring a Senior CMC Regulatory Technical Writer with experience in supporting Antibody-Drug Conjugate (ADC) products. This role involves authoring CMC documentation for late-stage clinical and commercial regulatory submissions.
Responsibilities
- Author, edit, and compile CMC regulatory documents for global submissions
- Prepare Module 3 sections of CTD/eCTD submissions
- Support regulatory filings including INDs, BLAs, MAAs, and lifecycle management submissions
- Collaborate with CMC, Regulatory Affairs, Quality, Analytical Development, Manufacturing, and Supply Chain teams
- Ensure documentation meets FDA, EMA, and global regulatory requirements
- Review technical reports and manufacturing documentation for regulatory accuracy
- Manage document timelines and support submission readiness
Skills
- Bachelor's, Master's, or PhD in Life Sciences, Pharmacy, Chemistry, or a related field
- 5+ years of CMC regulatory writing experience within the pharmaceutical or biotechnology industry
- Hands-on experience supporting Antibody-Drug Conjugate (ADC) products
- Strong understanding of biologics manufacturing, analytical methods, process development, and quality documentation
- Experience preparing regulatory submissions for late-stage clinical programs and marketing applications
- Familiarity with CTD/eCTD format and global regulatory requirements
- Excellent technical writing, editing, and communication skills
- Experience supporting FDA, EMA, and other global health authority submissions
- Experience with biologics or oncology products
- Familiarity with electronic document management systems (Veeva Vault, SharePoint, or similar)
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