Content Specialist CMC 55 views

Our people make all the difference in our success. Main Purpose of Job: The content specialist is responsible for providing accurate and timely regulatory CMC intelligence information for specific countries highlighting the differences with the standard CTD format. The content specialist will have a solid experience in the industry and will be familiar with CMC requirements worldwide. Duties and responsibilities: Monitor the evolution of CMC regulatory landscape worldwide Analyze the changes in the CMC requirements and implement them in the database. The content specialist must act as internal expert for a set of countries Work in collaboration with a pool of external consultants. Undertake the research and identification of local CMC experts, negotiation of contract terms and copyrights when needed. Provide support to CMC Product Manager Provide support and act as team representative for customers when required Communicate relevant information to concerned stakeholders. Knowledge, Skills, and qualification Minimum BS degree in Life Sciences 5 years’ experience on Pharmaceutical development, CMC manufacturing or CMC regulatory affairs. Strong knowledge of quality aspects of drug development and ICH requirements. Knowledge of Biological entities would be appreciated Experience on submissions, responses to deficiency letters and communications with health authorities on quality aspects of the product is required. Experience working with teams globally 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, good communication skills and proactivity. Fluent in English. Another European language would be appreciated

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