REGULATORY AFFAIRS – CHEMISTRY, MANUFACTURING , AND CONTROLS (CMC)/MANUFACTURING SCIENCES FELLOWSHIP
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Regulatory Affairs ‐ Chemistry, Manufacturing, and Controls (CMC) is one of the functional groups within the Regulatory Affairs organization that supports Biogen Idec's development and commercial programs.
The Regulatory Affairs CMC team is responsible for providing Biogen Idec with strategic, high quality, timely and decisive regulatory advice on complex manufacturing, quality, and analytical issues. This team utilizes a scientific and technical background along with comprehensive knowledge of global regulations to develop successful regulatory strategies and applications for the development of clinical products and life cycle management of commercial products. The Regulatory Affairs CMC group leads communications with regulatory agencies related to global chemistry, manufacturing, and controls.
Manufacturing Sciences fills a vital role in the drug supply network by linking the Research, Manufacturing, and Regulatory functions to promote a smooth transition of new products from development, into manufacturing, and on to eventual commercialization.
The Manufacturing Sciences team member works with many functional groups to contribute to three key activities: transfer of new products into manufacturing, troubleshoot and Improve drug production processes, and insure regulatory compliance of the production process and regulatory filings. In this capacity, the manufacturing sciences professional is instrumental in the dynamic and challenging environment required to manufacture biopharmaceuticals for a global market.
This two‐year Regulatory Affairs CMC/Manufacturing Sciences fellowship is designed to provide Ph.D. graduates with advanced hands‐on experience and develop professionals with comprehensive knowledge of chemistry, manufacturing, and controls and manufacturing sciences regulations and real‐world applications to drug development , from the biopharmaceutical perspectives. Regulatory Affairs CMC and Manufacturing Sciences are areas in which vital skills cannot be learned directly from solely a professional degree; rather, it requires on‐the‐job training and insight gained from experience.
Biogen Idec recognizes this critical need for experienced professionals. Regulatory CMC has partnered with the Manufacturing Sciences department to offer a Fellowship with opportunities to learn the following:
- Global regulatory environment that governs drug development
- Accurately and effectively applying regulations and providing sound guidance
- Manufacturing Sciences' role in drug development
The overall goal of the program is to prepare each fellow to be a successful Regulatory CMC or Manufacturing Sciences professional with a solid understanding of how global regulations are followed by the biopharmaceutical industry and enforced by regulatory agencies. Upon completion of the Fellowship, the experienced fellow will be well‐prepared to begin a career in Regulatory CMC or Manufacturing Sciences.