Navitas Life Sciences Hiring for Regulatory Associate- Trainee – Apply Now
With its headquarters located in Princeton, New Jersey, Navitas Life Sciences (“Company”) is a global clinical research organization (CRO) that leverages technology to provide full-service CRO, regulatory & safety, and outsourced data science services to big and mid-sized pharmaceutical clients.
Position Name : Regulatory Associate- Trainee
Organization : Navitas Life Sciences
Qualification: Bachelor’s Degree in Pharma
Experience: N/A
Salary: N/A
Location: Chennai, India
Job Title: Regulatory Associate
Location: Chennai, India
Job Type: Full-Time
Experience Level: Junior
Industry: Clinical Research
Education Requirement: Bachelor’s Degree in Pharma
Job Description:
We are seeking a detail-oriented Regulatory Associate to join our team. The ideal candidate will:
- Understand the requirements for various regulatory submissions, including IND, ANDA, NDA, and DMF in CTD/eCTD formats, for agencies such as US-FDA, EMA, and Health Canada.
- Assist Regulatory Associates and Senior Regulatory Associates with document-level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents as per guidelines.
- Provide submission publishing support, archiving, and review of same-day dispatch, major, and complex submissions.
- Ensure compliance with customer SOPs and policies, as well as adhering to the organization’s policies and procedures.
Desirable Skills and Experience:
- Experience in publishing and submissions is required.
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