Regulatory Affairs Specialist
Company: Encube
Location: Andheri (Marol), Mumbai
Qualification: M. Pharm
Experience: 3 – 6 years
About the Company
Encube Ethicals is a pharmaceutical manufacturer specializing in topical semisolid formulations for OTC and prescription drugs, as well as semisolid dose forms for cosmetic products.
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
- 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
