Navitas Life Sciences Hiring in Regulatory Affairs
About Company
Navitas Life Sciences is seeking a Regulatory Associate – Trainee to join our team. The successful candidate will be responsible for understanding the requirements of various regulatory submissions including IND, ANDA, NDA, and DMF in CTD/eCTD formats for regulatory agencies such as US-FDA, EMA, and Health Canada. Key responsibilities include assisting Regulatory Associates/Senior Regulatory Associates with document-level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents as per the guidelines. The role also involves providing Submission Publishing Support, archiving, and reviewing same-day dispatch, major/complex submissions. Adherence to customer SOPs and policies as well as organizational procedures is essential.
Position Details
Position Name | Regulatory Associate – Trainee |
---|---|
Organization | Navitas Life Sciences |
Qualification | B.Pharm, M.Pharm, Msc, BSc |
Experience | 0 Years / Freshers |
Salary | ₹25,000 – ₹35,000 per month |
Location | Chennai |
Key Responsibilities
- Regulatory Submissions: Understand requirements of regulatory submissions (IND, ANDA, NDA, DMF) in CTD/eCTD formats for various regulatory agencies (US-FDA, EMA, Health Canada).
- Document-Level Publishing: Assist with document-level publishing including bookmarking, hypertext linking, and preparing Tables of Contents.
- Submission Publishing Support: Provide submission publishing support, archiving, and review of same-day dispatch, major/complex submissions.
- Compliance: Ensure compliance with customer SOPs and policies as well as organizational procedures.
Desirable Skills and Experience
- Experience in publishing and submissions is required.
Application Instructions
Interested candidates can apply by sending their resume to recruitment.india@navitaslifesciences.com.
Excellent insights on the future of clinical research! At Novum Group, we’ve adapted quickly to the post-pandemic landscape by implementing flexible trial designs and hybrid models that combine virtual and in-person elements. This approach has allowed us to continue our research without compromising on quality or patient safety.
We invite everyone interested in the evolving landscape of clinical research to learn more about our adaptive strategies and innovations at Novum Group. Together, we can navigate the challenges and seize the opportunities that lie ahead in clinical research.
This post does an excellent job of outlining the challenges in global clinical trials. At Novum Group, we have extensive experience in managing the complexities of conducting trials across multiple regions. Our solutions include robust project management systems, culturally sensitive patient recruitment strategies, and a strong emphasis on regulatory compliance.
For those interested in understanding how Novum Group addresses the challenges of global clinical trials and ensures successful outcomes, visit our website Novum Group. We are always eager to share our insights and collaborate with others in the field.