Senior Publisher 813 818
Year Remote, India
Job Description
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Description
We are looking for an Regulatory Publisher to develop new challenging projects which would include the following responsibilities:
- Manage and prepare IND, NDA, BLA, and DMF regulatory applications in eCTD format for submission to the applicable regulatory authority (FDA/HC) in compliance with required timelines and specifications.
- Perform quality control procedures to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines.
- Perform document management tasks and post-submission activities including file transfer, tracking, database updates and archival.
- Maintain current knowledge of FDA, HC, and ICH requirements for regulatory submissions, and ensure compliance accordingly.
- Collaborate with global functional areas to ensure submission-related deliverables are met to achieve strategic business goals.
Education
Bachelor\xe2\x80\x99s degree in Life Sciences or related field, certificate in Regulatory Affairs is an asset
Experience
4 + Years max in RA (Publishing Plus)
Skills
- In-depth of Regulatory Affairs in EU Region. (Publishing Plus)
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Job Detail
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Job IdJD3029190
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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 LocationRemote, India
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EducationNot mentioned
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ExperienceYear