Regulatory Affairs - Officer (M.Pharma Fresher)

Job Description:

We have urgent Job Opening Regulatory Officer - for Pharma company Located in Daman.

Qualification :-  M.Pharma Fresher

Job Profile

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.

Intrsted candidtes can send resume on cv@qualityhr.co.in

Thanks

Quality HR Services

7203999100

9624999100