RA Officer

Job Description:

Position:       RA Officer

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.

Required Qualification: - B.Pharm/M. Pharm/B.Sc/M.Sc - Chemistry

Salary :- Upto 7.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-