CMC Dossier Lead - Regulatory Content & Strategy

US Tech Solutions; Morristown (TN); On-site; USD 80,000 - 100,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

Ability to understand technical reports

Experience in authoring submissions

Understand change controls

Experience in post-approval maintenance

Education

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

Job description

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.