Zydus life sciences fresher International Regulatory Affairs (IRA) job openings in the Ahmedabad location
IRA US (Fresher)
Location; Corporate Office|Corp. Office, Ahmedabad, Gujarat, India
Job posted on; Mar 14, 2023
Employee Type; C-C8-Confirmed-HO Executive
Experience range (Years) Fresher – 1 year
Job description (major activities):
- Submission compilation/publishing of electronic submissions: review, assembly, and publishing of submission documents. Can include pre-IND/NDA/ANDA submissions, original IND/NDA/ANDA, and life-cycle sequences (including Deficiency, Annual Reports, Amendments, and Supplements) as well as Clinical /BE Study Reports
- Performs submission build activities, including, but not limited to, ensuring submissions are built with submission-ready documents, creating inter-document links, performing a quality check and validating compiled submissions, and finalizing submissions by the required submission date
- Provide Bookmarking, Hyperlinking, and set PDF properties according to FDA recommendations for US regulatory submission.
- Review documents for submission readiness and conformity to FDA regulations and guidelines. Publishing Regulatory Submission by using EDUCE Software application.
- Communication with Educe Solution Software Team and Resolving the Query.
- Delivering the submission using ESG (Electronic Submission Gateway) to FDA Divisions (like CDER, OC)
- Provide formatting support for documents to ensure consistency within and between documents and with document templates
- Adherence to governmental regulations, company SOPs, local working instructions, and role-specific training relevant to Regulatory Operations
- Submissions of Drug Listing for both Manufacturer and Distributor.
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