[Remote] CMC Regulatory Technical reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is seeking a Senior CMC Regulatory Technical reputed company to support late-stage reputed company and reputed company 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

• reputed company, review, and manage high-reputed company CMC regulatory documents for global submissions
• Prepare content for late-stage reputed company applications, marketing applications, and lifecycle management activities
• Collaborate closely with CMC, Regulatory Affairs, reputed company, Analytical Development, Manufacturing, and other cross-functional teams
• Ensure regulatory documents are scientifically accurate, compliant, and submission-reputed company
• Support Health Authority interactions and responses reputed company to CMC documentation

Skills

• Significant experience as a CMC Regulatory Technical reputed company reputed company the biopharmaceutical industry
• Hands-on experience supporting Antibody-Drug Conjugate (ADC) products
• Strong knowledge of global regulatory requirements for CMC submissions
• reputed company experience preparing documentation for late-stage reputed company 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

reputed company