ProductLife Consulting
We offer a one-stop shop for consulting services dedicated to the life sciences
094 Publisher
004-placeholder Tunis, Tunisia - Onsite - Regulatory Operations 003-clock Permanent contract *
We are looking for an Regulatory Publisher to develop new challenging projects which would include the following responsibilities:
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’s degree in Life Sciences or related field
Experience
6 months to 2 years Job should have knowledge of Power Point, Microsoft, Computer related activities.
094 Publisher
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