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About Company

Pharmaceutical manufacturer Encube Ethicals specializes on topical semisolid formulations for OTC and prescription drugs, as well as semisolid dose forms for cosmetic products.

Position Name :

Regulatory Affairs Specialist

Organization :

Encube

Qualification:

M. Pharm

Experience:

3 - 6 years

Salary:

N/A

Location:

Andheri (Marol), Mumbai

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.