CMC Dossier Lead - Regulatory Content & Strategy

US Tech Solutions; Morristown (TN); Vor Ort; USD 80.000 - 100.000; Vollzeit

Zusammenfassung

A global staff augmentation firm is seeking a CMC Manager to support the Morristown team. You will be responsible for drafting technical registration documents and ensuring compliance with industry standards. The ideal candidate possesses a degree in the sciences and has experience in authoring submissions as well as managing change controls. Strong technical report comprehension and post-approval product maintenance experience are essential. Join us to contribute to the growth and success of our clients.

Qualifikationen

• Degree in the sciences required.
• Experience in authoring submissions and change controls is essential.
• Strong understanding of technical reports and post-approval maintenance needed.

Aufgaben

• Draft or update technical registration dossiers for pharmaceutical products.
• Evaluate change requests and define technical requirements according to guidelines.
• Coordinate preparation of draft responses to technical-regulatory questions.

Kenntnisse

Ability to understand technical reports

Experience in authoring submissions

Understand change controls

Experience in post-approval maintenance

Ausbildung

Degree in the sciences (chemistry, biology, etc.)

Jobbeschreibung

A global staff augmentation firm is seeking a CMC Manager to support the Morristown team. You will be responsible for drafting technical registration documents and ensuring compliance with industry standards. The ideal candidate possesses a degree in the sciences and has experience in authoring submissions as well as managing change controls. Strong technical report comprehension and post-approval product maintenance experience are essential. Join us to contribute to the growth and success of our clients.