Vacancy for Regulatory Affairs Executive at Piramal Healthcare
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 – (210000UO)
Key Roles / Responsibilities
• 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.
• 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
• Minimum 2 to 3 years relevant experience in handling Europe market. Over all total experience in Regulatory of 3-5 years
Qualification : B.Pharm / M.Pharm / M.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 5th May, 2021