Global Device Regulatory CMC Manager

Vertex Pharmaceuticals LLC; United States; Sur place; USD 103 000 - 110 000; Plein temps

Résumé du poste

Vertex Pharmaceuticals LLC in the United States seeks a Chemistry Manufacturing Controls Manager – Device to lead regulatory CMC strategies for drug-device combination products. You will support regulatory submissions and provide guidance to cross-functional teams to ensure global requirements are incorporated.

The role requires a Bachelor's degree in a life-science field and typically 4+ years in pharma or medical devices, with experience in submissions and human factors.

Qualifications

• Bachelor's degree in a life-science field.
• Typically 4+ years in medical device or pharmaceutical industries.
• Experience supporting regulatory submissions for combination products.
• Experience with Human Factors studies for devices.
• Preferred infusion systems/devices experience.

Responsabilités

• Reviews CMC sections of regulatory submissions for development and commercial devices.
• Contributes to global regulatory CMC strategies for combo products.
• Participates on cross-functional teams and may serve as primary CMC contact.
• Reviews device development documentation to support design controls.
• Supports regulatory assessment on change controls and process improvements.

Connaissances

CMC regulatory

Cross-functional comms

Regulatory knowledge

Design Controls

Submissions experience

Problem solving

Planning & prioritization

Formation

Bachelor’s degree

Description du poste

Vertex Pharmaceuticals LLC in the United States seeks a Chemistry Manufacturing Controls Manager – Device to lead regulatory CMC strategies for drug-device combination products. You will support regulatory submissions and provide guidance to cross-functional teams to ensure global requirements are incorporated.

The role requires a Bachelor's degree in a life-science field and typically 4+ years in pharma or medical devices, with experience in submissions and human factors.