Zydus life sciences fresher International Regulatory Affairs (IRA) job openings in the Ahmedabad
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
Division; IRA
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.
