Require Regulatory Editor at Clarivate Analytics
Clarivate Analytics is the global leader in providing trusted insights and analytics to accelerate the pace of innovation. Building on a heritage going back more than a century and a half, we have built some of the most trusted brands across the innovation lifecycle, including Web of Science, Cortellis, Derwent, CompuMark, MarkMonitor and Techstreet. Today, Clarivate Analytics is a new and independent company on a bold entrepreneurial mission to help our clients radically reduce the time from new ideas to life-changing innovations.
Post : Regulatory Editor, Cortellis CMC Expert
The Regulatory Editor, Cortellis CMC Expert, will play a key role in the development and update of CMC information. This role will support the Managing Editor in defining CMC needs worldwide, focusing more particularly on the critic analysis of key country requirements, highlighting the differences with CTD format that may influence or impact companies’ strategy to enter the market (e.g.: stability requirements, GMP certificate acceptance, business/local representative requirements, etc.).
Duties and responsibilities:
1. Development and maintenance of CMC regulatory database content & maintenance of content
• Author high-quality CMC reports for biologics to ease Health Regulatory Agencies submission, facilitate the application of CMC global regulatory strategies, helping to assure technical congruency and regulatory compliance to customers.
• Understanding of scientific principles and regulatory CMC requirements relevant to vaccine development, biologics and/or biopharmaceutical products and registration.
• Actively participate in CMC content development as per project schedule, acting as internal CMC regulatory expert for a set of countries
• Real time monitoring of changes and evolution of CMC regulatory landscape worldwide
• Analyze changes in the CMC requirements and implement changes in the database capitalizing on internal expertise and external network of consultants for local expertise and practice.
2. Administrative tasks
• Participate in research to identify local CMC experts, negotiation of contract terms and negotiate copyrights when needed, budget follow-up and monitoring, when needed
3. Customers/internal support
• Provide support to CMC Product Manager
• Provide customer support and expertise
• Minimum BS degree in Life Sciences
• 5 years’ experience on Pharmaceutical development CMC manufacturing or CMC regulatory affairs for Biologics and/or Biopharmaceutical products.
• Experience with managing BLA/MAA content and format.
• Strong knowledge of ICH requirements for quality aspects for Biologics and/or Biopharmaceutical products.
• Knowledge of Biological entities appreciated
• Experience on FDA and EMA submissions and responses to deficiency letters and communications with health authorities on quality aspects of the product is required.
• Working knowledge/experience in regulatory submission and approval processes for new Biologics or biopharmaceutical products and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements
• Experience working with teams globally. Ability to work successfully with extended, multinational project teams on multiple tasks under pressure of time and workload.
• Demonstrated ability to work collaboratively and resolve conflict across different functional areas in a highly matrixed organization.
• Good problem solver and able to demonstrate good judgment in decision making and setting priorities.
• Capability to work remotely with peers in an international environment
• Team spirit and good communication skills and proactivity.
• Fluent in English and French or English and Spanish. Another language would be appreciated.
Experience: 5 years
Educational Qualification: BS degree in Life Sciences
Functional Area : Cortellis CMC Expert
End Date : 25th April, 2019
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