Work as Regulatory Affairs Executive at Piramal Healthcare Limited

Piramal Healthcare Limited A major force in the pharmaceuticals and healthcare segment, Piramal Healthcare Limited, incorporating Healthcare Solutions and Pharma Solutions, has an unequivocal vision to become the most admired pharmaceutical company, with leadership in market share and profits.

Post : Executive Regulatory Affairs

Job Description
Under the guidance of the Team Leader, this person should be able: 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 Profile
B.Pharm / M.Pharm / M.Sc. degree in a related field. 2 to 5 years experience in regulatory affairs preferred, supporting LATAM / US region and/or ROW region. 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
Experience : 2 to 5 years
Qualification : B.Pharm / M.Pharm / M.Sc
Location : Maharashtra - Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th October, 2021