Content Editor (cmc)
Job Description
Minimum BS degree in Life Sciences 3-5 years experience on pharmaceutical development, CMC manufacturing or CMC regulatory affairs. Strong knowledge of quality aspects of drug development and ICH requirements. Experience on submissions, post-approval changes, responses to deficiency letters and communications with health authorities on quality aspects of the product is required. It would be great if you also had . . . Knowledge of Biological entities would be appreciated. Knowledge of another European language. What will you be doing in this role Maintenance of the CMC regulatory database Monitor the evolution of CMC regulatory landscape worldwide. Analyze the changes in the CMC requirements and implement them in the database. The content editor must act as internal expert for a set of countries. Work in collaboration with a pool of external consultants. Administrative tasks Undertake the research and identification of local CMC experts, negotiation of contract terms and copyrights when needed. Customers/internal support Provide support and act as team representative for customers when required. Communicate relevant information to concerned stakeholders.
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Job Detail
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Job IdJD3162118
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationHyderabad, Telangana - Secunderabad, Telangana, India
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EducationNot mentioned
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ExperienceYear