Regulatory CMC Manager

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $75 - $80 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Vertex Pharmaceuticals

WebsiteLinkedInAll Job Openings

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

• Support execution of multi-product global regulatory CMC for marketed products • Prepare and submit regulatory CMC documentation, including clinical trial submissions • Provide regulatory support to cross-functional teams with a focus on Biologics • Execute commercial Lifecycle Management strategy and submissions focused on US/Canada/Europe • Review CMC sections of regulatory submissions and interactions and responses with regulatory agencies • Develop global regulatory CMC strategies and submissions with regulatory colleagues • Participate on cross-functional teams • Serve as the primary regulatory CMC contact for assigned products and projects

🎯 Requirements

• Bachelor's degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field • Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience • Proficiency in FDA, EMA, Health Canada and ICH regulatory guidelines • Sound knowledge of cGMP, FDA, EMA, ICH • Strong problem-solving skills • Strong planning and prioritization skills • Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner • Ability to work with all levels of management • Strong interpersonal skills to exchange complex information with others and to guide others

🏖️ Benefits

• Overtime pay in accordance with federal and state requirements • Compensation and medical benefits will be presented by the third-party agency partner upon offer • Fringe benefits and other employment terms will be presented by the third-party agency partner upon offer