Opportunity for M.Pharm, B.Pharm, M.Sc as Regulatory Affairs Executive at Piramal Enterprises

 

Piramal Enterprises Limited is the flagship company of the Piramal Group.  Starting from the mid-1980s, PEL has shifted its focus from the textiles industry, and established its entrepreneurial credentials in Pharma, Information Management, and Financial Services. It has grown organically and inorganically and often made contrarian business calls.  When Indian pharmaceutical industry was focused on international generics, we invested in domestic formulation businesses.

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.

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

Additional Information
Qualification : M.Pharm/B.Pharm/MSc
Location : Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 20th February, 2019

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