Zydus Lifesciences Limited Walk In Interview 2023.Zydus Lifesciences Limited Notification full details below. Interested and eligible candidates can attend Interview on scheduled time and venue.The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
- DESIGNATION: IRA US (Fresher)
- Experienced:00 – 1 year
Job Description: Greeting from Zydus Lifesciences Limited !!!!
Important Details :
- Location: Ahmedabad, Gujarat, India
- Post of date:15/03/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face interview
- Interview Rounds of Interview: HR
Key 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.