Vertex Pharmaceuticals
1001 - 5000 employees
Founded 1989
🏥 Healthcare
💼 Consulting
🏭 Manufacturing
Healthcare • Consulting • Manufacturing
Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.
Regulatory CMC Manager – Small Molecule
Job not on LinkedIn
🕒 5 days ago
🇺🇸 United States – Remote
💵 $70 - $80 / hour
⏳ Contract/Temporary
🟡 Mid-level
🟠 Senior
🚔 Compliance
🦅 H1B Visa Sponsor
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Vertex Pharmaceuticals
1001 - 5000 employees
Founded 1989
🏥 Healthcare
💼 Consulting
🏭 Manufacturing
Healthcare • Consulting • Manufacturing
Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.
📋 Description
• Responsible for the detailed planning, preparation and operational execution of a multi-product program in the international region • Contributes to the preparation and submission of regulatory CMC documentation • Executes Lifecycle Management (LCM) strategy and submissions of marketed products with a focus in the international regions • Planning and execution of international regulatory CMC submissions • Reviews CMC sections of regulatory submissions • Works with regulatory colleagues in development of global regulatory CMC strategies and submissions • Participates effectively in cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
🎯 Requirements
• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field • Typically requires 5 years of experience in the pharmaceutical industry or related field • Experience supporting Small Molecule programs required
🏖️ Benefits
• Eligible for overtime pay, in accordance with federal and state requirements
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