CMC Regulatory Manager: Global Dossier Lead

Us tech Solutions; Morristown (TN); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Us tech Solutions is seeking a CMC Manager in Morristown, TN. The role involves leading the development of Chemistry, Manufacturing, and Control (CTD Module 3) documentation for regulatory submissions. The candidate will ensure that documents are of high quality and meet industry standards.

The ideal applicant will have a Bachelor’s degree and significant experience in regulatory environments. Key skills include excellent writing and analytical abilities, as well as CMC documentation experience. The position will be managerial in nature, coordinating with project teams on regulatory submissions.

Qualifikationen

• Bachelor’s degree with 4+ years of proven experience or Master's degree with 2+ years of proven experience.
• Experience in CMC/Module 3 documentation.
• Excellent writing skills are essential.

Aufgaben

• Lead the development of CTD Module 3 and QOS documents for submission.
• Align with project teams on strategy for product maintenance.
• Evaluate change requests to define technical requirements.
• Create or update technical registration dossiers.
• Maintain knowledge of current regulatory requirements.
• Coordinate responses to regulatory questions.

Kenntnisse

Experience in global CMC/Module 3 creation

Analyzing technical reports (manufacturing, analytical and stability)

Experienced in the US regulatory environment

Experience in post‑approval CMC changes

Excellent writing skills

Managing IT based scientific systems

Ausbildung

Bachelor’s degree with 4 or more years of proven experience

Master’s degree with 2 or more years of proven experience

Jobbeschreibung

Us tech Solutions is seeking a CMC Manager in Morristown, TN. The role involves leading the development of Chemistry, Manufacturing, and Control (CTD Module 3) documentation for regulatory submissions. The candidate will ensure that documents are of high quality and meet industry standards.

The ideal applicant will have a Bachelor’s degree and significant experience in regulatory environments. Key skills include excellent writing and analytical abilities, as well as CMC documentation experience. The position will be managerial in nature, coordinating with project teams on regulatory submissions.