Piramal Healthcare Limited A major force in the pharmaceuticals and healthcare segment, Piramal Healthcare Limited, incorporating Healthcare Solutions & Pharma Solutions, has an unequivocal vision – to become the most admired pharmaceutical company, with leadership in market share and profits.
Post : Executive Regulatory Affairs - (200002EC)
Job Description
• To submit the product registration dossier of assigned products to targeted countries in Europe as per eCTD requirements.
• To file all the required variations and Renewals of assigned products in line with guidelines and checklists as per the plan.
• To respond to queries received from regulatory agencies, business unit or other stake holders by ensuring complete and accurate information is provided within predefined timelines.
• To review product labeling updates in EU.
• To maintenance of various data bases in timely manner.
• To update himself/herself with the relevant current EMEA, National and ICH guidance’s and requirements.
• To provide required support to Pharmacovigilance team as and when required
• To ensure support in execution of any projects assigned as per business need.
Candidate Proflie
• Minimum 2 to 3 years relevant experience in handling Europe market. Over all total experience in Regulatory of 3-5 years
• Good communication skills both spoken and written English
• Should be well versed with using excel sheets, Power Point etc.
• Ready to take challenges in work
• Ready to move to different locations for work as and when required
• Will need to do coordination intra and inter department and across sites globally
• Should be good at review of documents and should have good technical knowledge
• Should be able to do multi-tasking
Additional Information
Qualification : M. Pharm/B. Pharm/Msc
Location : Kurla (West) Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th December, 2020
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