Sr. Executive/Asst. Manager - RA

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.
• Good communication.

Qualifications

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