Sibitalent Corp is hiring : Technical Writer in Morristown

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Note : Must have 5 years of experience in Pharma..........................................

Job Description

The CMC Regulatory Technical Writer II is a member of the CMC Dossier Development team and participates in Our Client’s lifecycle management (LCM) programs. They collaborate directly with Our Client's global business units (GBU) - Specialty Care, Vaccines, General Medicines, and Consumer Healthcare - by contributing to US, EU, and ROW dossiers (e.g., NDA, MAA, IND, and IMPD).

Key Responsibilities :

• Develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers within established timelines.
• Handles responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports. Authors and evaluates change controls for global regulatory impact. May also author technical reports, position papers, white papers, or SOPs.
• Ensures regulatory dossier compliance and independently authors high-quality CMC content by :
• Following regulatory guidelines, source documentation, and client templates
• Collaborating with key stakeholders across GBUs, contract manufacturing organizations (CMO), and functions such as Quality, Manufacturing, and Global Regulatory Affairs (GRA)
• Minimizing unsolicited regulatory burden
• Supporting development of regulatory risk mitigation strategies
• Maintaining up-to-date knowledge of Our Client's SOPs and CMC regulations and guidelines
• Supporting planning and timeline management

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