Job Summary

Position: Sr. Executive/Asst. Manager - RA

Location: Daman

Experience: 5 - 8 Years

Industries: Pharma

Responsibilities
Preparation of the dossier as per the current prescribed guidelines of the respective regulatory authorities
Coordinate with various departments to collect the complete set of documents.
Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, batch records, stability, finished product / packaging material data for the purpose of compilation of dossier.
Review of documents required for regulatory agencies (Viz DMF, analytical reports, process validation reports, PVP, PDR, protocols stability data)
Preparation of various pharmacological, preclinical and toxicological data based on published literature




Submission of the notification to regulatory agency for the post approval changes.
Preparation of SPC, package insert and labeling information.
Review of vendor documents as a part of vendor qualification programmer and to communicate with supplier manufacturer of the API Excipients for the related vendor documents
Preparation of template of the vendor quality Agreement and to communicate with the vendor for its final execution
Any other work assigned by management within the scope of regulatory framework.

Required Skills
Logical thinking.
Organizing.
Valuable communication.

Qualifications B.Pharm/M. Pharm/B.Sc/M.Sc - Chemistry

📌 Sr Executive/asst Manager Ra Daman
🏢 Quality HR Services
📍 Daman