Vertex Pharmaceuticals
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.
Director, Regulatory Strategy – Contract
🕒 May 29
🇺🇸 United States – Remote
💵 $115 - $125 / hour
⏳ Contract/Temporary
🔴 Lead
🚔 Compliance
🦅 H1B Visa Sponsor
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Vertex Pharmaceuticals
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
• Lead the development of regulatory strategy for assigned projects/regions in development • Shape the regulatory strategy for regulatory submission documents and Health Authority communications • Manage project plans and timelines to ensure all projects are appropriately prioritized and key goals are met on time • Provide regulatory leadership to the GRA functional team(s) or projects with moderate resource requirements or complexity
🎯 Requirements
• Bachelor's degree in Biology, Chemistry, or other related discipline • 10 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience • Experience with market product, labeling, new drug development and working with the FDA required • Advanced technical skill in regulatory affairs science including knowledge of regulatory frameworks and external environments. • Proficient knowledge of the research and development, preclinical and clinical requirements related to drug development registration, and maintenance of human pharmaceuticals.
🏖️ Benefits
• compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. • Eligible for overtime pay in accordance with federal and state requirements.
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