Regulatory Analysts

1-3 years
130000 - 440000 INR
3 months ago 28 Applied
Job Description

Reviewing, Compilation, and Preparation of Registration Dossiers CTD, ACTD, ECTD & country-specific Dossiers as per country's guidelines.

Handling registration queries.

Review technical documents like specifications, Certificate of Analysis, Method of Analysis, Test Methods, Testing Reports, Stability Protocols, Stability Data & Product Development Reports.

Artwork development: Checking of Artwork, leaflets and labels, requirements for labelling, storage & approval for the same. (Preparation of Patient Information Leaflet)

Preparation of Quality Overall Summary & clinical Summary as per requirement.

Preparation & checking of Finished Product Certificate of Analysis.

Co-ordinate with other departments of Production, QA & QC on requirements, issues related to deficiencies and any technical problem.

Coordinating with QA, QC & Production to arrange Registration Documents, Finished Products & Working Standard Samples.

Handling Tender supply requirements.

Drafting of Label claim compositions.

Studying scientific & Legal documents.

Application for legal documents such as Manufacturing License, Product Permissions, FSCs, COPPs etc. for registration purposes and as per requirement.

Responsible for getting FDA documents

Responsible for SOP Preparation.

Arranging the samples (reference samples) for Registration Purposes.

Updating Registration Sheet.

To maintain and update all documents and dossier records.

To update registration status.

JOB TYPE

Industry

Education

Bachelor of Commerce (B.Com)
Bachelor Of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)

Pharma

About Recruiter
Deepali Bhor

Functions

IT

Industry

Other

Skills/Roles

Manager

LEVEL HIRING FOR

Top Management