Bal Pharma Limited requires Executive/Asst Manager - Regulatory Affairs
Bal Pharma Limited.,a Rs.100 crore Pharmaceutical company is among the pioneer pharmaceutical companies that strive on innovation & research and is acknowledged globally.
Post: Executive/Asst Manager-Regulatory Affairs
-Collection, preparation of dossiers to Africa, Middles East CIS Countries, Latin America, South East Asia as per current MOH guidelines.
-Review, submission of quality dossiers as per the current guideline (country specific) requirements and attending the MOH query.
-Collection of dossier documents from various departments like QC, QA, Stores, Production, FD, Stability and maintaining in a master document with systematic manner.
-Coordinating with International marketing dept for the submission of Quality Dossiers and to reply the response for the queries.
-Organizing, preparation, submission of the tender document with in a short period and attending the MOH query.
-Attending the queries and providing the accurate response for the quires.
-Collection of DMF from suppliers for dossier preparation.
-Supporting clinical Pharmacokinetic, Physiological properties Bioavailability, BE published document for dossier preparation.
-Data Bank Management (Regulatory Document Server).
-Updating the MOH guidelines from online.
-Having Knowledge about GMP, WHO GMP, Manufacturing Licence, Product Licence, COPP, FSC, attestation of documents from various embassies.
-Having Knowledge about BE and eCTD submission.
Candidate should be B.Pharm/M.Pharm with 1-8 years of releavent experience.
Experience: 1-8 years
Education: B.Pharm, M.Pharm
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Regulatory affairs
Apply/Send resume at, firstname.lastname@example.org
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