Experience

Indus Pharma (Pvt.) Ltd.

• Pakistan
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• • Jul 2016 - Present

• • Jan 2015 - Present

  Export:>Responsible for the preparation, maintenance, and timely completion of regulatory documents to support submissions to international Market.>Updating of regulatory information & guidance at different stages of product development.>Preparation and review of the dossiers as per the current prescribed guidelines of the respective regulatory authorities.>Answer any regulatory related query's from authorities and internal departments Support supply and marketing team accordingly.>Perform additional regulatory related duties as and when required, assigned by the IRA team leader.>Application of legal documents like Product license, Certificate of Pharmaceutical product, Free sale certificate according to the FDA/WHO regulations.>Collection of various pharmacological, pre-clinical & toxicological data.>Compilation of registration and renewal dossiers and respond for queries for , Uganda, Sudan, Vietnam, Afghanistan, Rwanda, Burundi, Kazakhstan, Tajikistan, Nigeria, Uzbekistan, Turkmenistan , Philippines,Myanmmar,Sri Lanka, Jordan,&Ivory Coast etc.>Produce regulatory dossiers, new registrations, renewals and variations.>Prepare CTD's (Common Technical Document),ACTD>Email correspondence/co-ordination to various departments.>Coordinating in sample management and submission to the regulatory authorities.>Interdepartmental coordination to provide data/information to relevant personnel.NATIONAL (Local):• Prepare applications on Form-5B for the Renewal of drugs already registered in Drugs Regulatory Authority of Pakistan (DRAP) and maintain registration of currently approved products.ARTWORK:• Proofreading of developed packaging material’s artwork such as printed boxes, leaflets, labels, ampoules and other relevant literature of the drugs.• Proofreading of New Packaging materials artwork such as printed boxes, leaflets, labels, ampoule and other relevant literature of the drugs. Show less