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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