Website PSA Chemical & Pharmaceutical Ltd.
Executive / Sr. Executive – Regulatory Affairs
Desired Eligibility :-
Pharma. Graduate and/or Post-Graduate in Science
Minimum 2 – 4 years relevant experience.
As per industry norms.
1)Should be well versed with the guidelines of ICH and other regulatory.
2)Should be well versed with the preparation of documents for license application.
3)Should be well versed with the preparation of documents for COPP, FSC and other legal documents.
4)Should be well versed with the preparation of registration documents as per ACTD, CTD, country format.
5)Preparation of text matter and checking of artworks.
6)Should coordinate with factory for samples, working standards, document data, license related documents.
7)Should have knowledge with regard to checking of samples.
8)Courier of documents and samples to respective customer.
9)Maintaining status and record of dossiers, samples & legal documents.
10)Reply of queries.
11)Co-ordinate with regard to legalization of documents.
12)Maintaining record of registration status and re-registration.