Assistant Manager Submission Publishing
Job Description
Compile high quality submissions in compliance with technical requirements from regulatory authorities Project team participation to identify appropriate planning, formats, deliverables, and timelines associated with investigational and marketed product submissions across all therapeutic areas. Coordinate submission publishing activities among internal Regulatory functions and work with external Submission technical resources for dispatch (agency submission gateway). Provide support as necessary to assure high quality published output and to meet established deadlines. Support submission related to Initial, variations, deficiency and renewals Input submission tracking information into registration tracking system. Represent RA Operations on Regulatory sub teams as necessary, escalate timeline issues. Implement internal process and standards relating to publishing Demonstrated ability to quickly learn new technology Expertise in Electronic Document management systems, submission publishing, Adobe Acrobat or demonstrated experience with similar tools Knowledge of regulations and instructions Expertise with electronic submission formats like eCTD, ACTD and NeeS
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Job Detail
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Job IdJD3104857
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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 LocationMumbai, Maharashtra, India
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EducationNot mentioned
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ExperienceYear