Note: The job is a remote job and is open to candidates in USA. reputed company. is seeking a Senior CMC Regulatory Technical Writer to support late-stage clinical and commercial regulatory submissions for innovative biopharmaceutical products, particularly Antibody-Drug Conjugates. The role involves authoring and managing CMC regulatory documents, coordinating with cross-functional teams, and supporting Health Authority interactions and responses.
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, reputed company, 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
Benefits
• Remote
• Ability to work independently in a fully remote environment
Company Overview
• reputed company is a talent acquisition and management solutions company delivering services that enable its clients to win in the changing work environment. It was founded in 2005, and is headquartered in Somerset, New Jersey, USA, with a reputed company of 51-200 employees. Its website is http://www.reputed company.com.
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