Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries. At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology-driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients.
- Vacancy details:
- Department: REGULATORY ASSOCIATE – TRAINEE
- Experience: 2Â –Â 7Â years
- Qualification: Bachelor’s DegreeÂ
- Salary:₹Not Disclosed
Job Description : Greeting from Navitas Life Sciences Pvt Ltd.!!!!
- Important Details :
- Location: Chennai, India
- Post of date:23/07/2024
- Selection Process: The selection will be on the basis of Interview.
Job Description
We are looking for a Regulatory Associate. The successful candidate will:
- Understand the requirements of various regulatory submissions including: IND, ANDA, NDA and DMF in CTD/eCTD formats for various regulatory agencies including: US-FDA, EMA, Health Canada, etc.
- Assist Regulatory Associates/Senior Regulatory Associates with document level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents as per the guidelines.
- Provide Submission Publishing Support, archiving and/or review of same day dispatch, major/complex submissions
- Be compliant with customer SOP’s and Policies as well as adhering to the organization’s policies and procedures
Desirable Skills and Experience
- Experience in Publishing and Submissions is required
