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WHAT
IN
Regulatory CMC Manager
Job
Vertex Pharmaceuticals
US
-
Cambridge,
Massachusetts
Job Code - 987BR
Position - FULL TIME
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Vertex Pharmaceuticals for this position!)
JOB DESCRIPTION: Regulatory CMC Manager
The Regulatory CMC Manager is responsible for developing and implementing innovative global regulatory CMC strategies in support of projects at various stages of drug development. The Regulatory CMC Manager is responsible for the preparation of regulatory CMC documents, submissions, and the identification of compliance issues. Vertex is committed to Quality by Design (QbD) and the Manager is responsible for integrating QbD into regulatory filings consistent with FDA's pharmaceutical quality initiatives for the 21st century. In addition, the CMC Manager represents the regulatory department with contractors and corporate partners, and may serve as the regulatory CMC contact with relevant regulatory authorities, as determined by senior management. This role is responsible for the implementation of assigned projects and services, with optimal efficiency, through effective leadership, as well as the work performance and technical development of their staff.
Key Responsibilities
• Directs the planning, writing and coordination of clear and effective of regulatory CMC submissions
• Develops strategies for integrating Quality by Design (QbD) into regulatory filings consistent with FDA's pharmaceutical quality initiatives for the 21st century
• Ensures the alignment of regulatory CMC strategy with department and corporate objectives, for assigned projects
• Prepares and delivers effective regulatory CMC presentations for internal and external audiences
• Ensures electronic submissions adhere to current regulatory submission practices
• Participates in the design, development and implementation of department strategies, providing recommendations in their area of expertise
• Leads cross-functional teams on assigned projects to successful conclusions
• Communicates clearly and effectively with regulatory authorities, where relevant
• Regularly interacts with subordinates, outside contacts and functional peer groups at various management levels
• Builds and maintains excellent relationships with contractors and corporate partners
REQUIREMENTS - QUALIFICATIONS: Regulatory CMC Manager
• Demonstrates expert knowledge of FDA regulations, guidelines, and precedents related to drug product development, including Quality by Design (QbD) initiatives
• Knowledge of EU, Canada and ROW regulations, guidelines and precedents
• Proven ability to impact team decision making
• Ability to communicate with all levels within the company and can act as liaison / representative both internally and externally
• Exhibits project management skills necessary to perform complex tasks independently and work on multiple projects simultaneously
• Has a proven track record of successful interaction with regulatory authorities and in preparation of major regulatory submissions
• M.S. (or equivalent degree) and 4+ years of relevant work experience
• B.S. (or equivalent degree) and 6+ years of relevant work experience
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Vertex Pharmaceuticals
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