Job Title: Regulatory Affairs Specialist
Company: Encube
Location: Andheri (Marol), Mumbai
Qualification: M. Pharm
Experience: 3 – 6 years
Key Responsibilities:
- Review and compile Dossiers for ANDAs for the US Market.
- Manage post-approval activities for the US.
- Review documents such as Specifications, Batch Records, Method Validation Documents, Stability Data, Container Closure System, and DMFs.
- Operate electronic submission systems (eCTD and SPL).
- Conduct labeling-related activities.
Skills and Requirements:
- Experience in US submissions.
- Knowledge of reviewing CMC documentation required for submission.
- Proficiency in using PharmaReady software.
- Understanding of labeling-related guidelines.
- Positive attitude and willingness to learn.
How to Apply:
Interested candidates can share their resumes at pranali.sarvagod@encubeethicals.com.
