Regulatory CMC Manager – Cell & Gene Therapy

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $70 - $80 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

😶‍🌫️ Therapist

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Vertex Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1989

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Support the execution of cell and gene therapy regulatory CMC strategies for marketed products • Planning and execution of international regulatory CMC submissions, including creation of content plans and ensuring cross functional alignment • Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies • Contributes to the development of global regulatory CMC strategies for commercial products • Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment • Provides regulatory CMC guidance to cross-functional teams and key stakeholders • Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

🎯 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 • 5 years of Regulatory CMC experience, including Cell & Gene Therapy Regulatory CMC experience • Proficiency in FDA, EMA and international regulatory guidelines • Strong interpersonal skills to exchange complex information with others and to guide others • Experience in the preparation, reviews and submissions of CMC post approval variations • Strong sense of planning, strategic thinking and problem-solving skills • Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner • Capable of strategic thinking with ability to resolve complex and ambiguous situations

🏖️ Benefits

• Overtime pay in accordance with federal and state requirements