Zydus Hiring IRA US (Fresher)
Corporate Office|Corp. Office, Ahmedabad, Gujarat, India
IRA
C-C8-Confirmed-HO Executive
0 - 1 year
Job Description:
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 quality check and validating compiled submissions, and finalizing submission by 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.
Top Regulatory Affairs Pharmacy Courses launched on Udemy 📖👨🎓👩🎓✌
1) New USFDA Electronic Submission Gateway Course-Regulatory Affairs
👉Apply Coupon Link: Click here
2) Title : Pharmaceutical Clinical Research course
👉Apply Coupon Link: click here
3) Title: Pharma Drug Regulatory Affairs Course
👉Apply Offer link : Click here
4) Title: Pharma eCTD & CTD preparartion + Sumbmission course
👉Apply Coupon Link: Click here
For more details click on given links
No comments:
Post a Comment
Thank you for Your response