Note: The job is a remote job and is open to candidates in USA. Employvision Inc. is seeking an experienced Senior CMC Regulatory Technical Writer with a strong background in Antibody-Drug Conjugates (ADCs) to support late-stage clinical and commercial regulatory submissions for innovative biopharmaceutical products. The role involves authoring and managing regulatory documents, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.
Responsibilities
- Author, review, and manage high-quality CMC regulatory documents for global submissions
- Prepare content for late-stage clinical applications, marketing applications, and lifecycle management activities
- Collaborate closely with CMC, Regulatory Affairs, Quality, Analytical Development, Manufacturing, and other cross-functional teams
- Ensure regulatory documents are scientifically accurate, compliant, and submission-ready
- Support Health Authority interactions and responses related to CMC documentation
Skills
- Significant experience as a CMC Regulatory Technical Writer within the biopharmaceutical industry
- Hands-on experience supporting Antibody-Drug Conjugate (ADC) products
- Strong knowledge of global regulatory requirements for CMC submissions
- Proven experience preparing documentation for late-stage clinical development programs and marketing authorization applications
- Excellent scientific writing, editing, and communication skills
- Ability to work independently in a fully remote environment
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