Regulatory Affairs Associate
Job Description
1. 2-4 yrs of experience in a regulatory environment with preference given to drug/device/biologic-related industry, and experience with electronic publishing of regulatory submissions. 2.Compilation, publishing, and technical quality control of Regulatory submissions (Nees, paper and eCTD format) including technical troubleshooting to ensure issues within submissions are resolved and deadlines met. 3. Creation of cross-references, table of content, tab / slip-sheets, and volumes for Paper submissions. 4. Performing bookmarking, hyper-linking, and tables of content creation according to Health Authority (HA) guidelines for Electronic Submissions. 5. Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures preferred. Knowledge of submission requirements of various markets such as USFDA, EMA etc. is preferable. 6.Good communication, organizational, and interpersonal skills. 7. Knowledge of submission dispatches to Health Authorities is preferrable. Qualification B.Pharm- Regulatory Affairs/M. Pharm- Regulatory Affairs
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Job Detail
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Job IdJD3067545
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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 LocationBangalore, Karnataka, India
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EducationNot mentioned
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ExperienceYear