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 if necessary.
• To ensure support in execution of any projects assigned as per business need.
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 if necessary.
• To ensure support in execution of any projects assigned as per business need.
Candidate Profile
• 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
• 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 : Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 20th February, 2019
Qualification : M.Pharm/B.Pharm/MSc
Location : Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 20th February, 2019
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