Piramal Life Sciences Limited (PLSL) is an independent research-driven drug company that was recently demerged from Piramal Healthcare Limited (Formerly known as Nicholas Piramal India Limited). PLSL was formerly the NCE R&D division of NPIL. PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development.
Post: Manager - Critical Care - Regulatory Affairs
Job Responsibilities:
- Should have handled regulated markets especially Europe for at least 7-8 years
- Should have experience of handling submissions through DCP /MRP procedures and also query responses
- Should have experience of doing post approval activities (Renewals, variations etc)
- Good communication skills both spoken and written English
- Should have experience of doing e-CTD submission.
- Should be well versed with using excel sheets, Power Point etc
- Should be a team player
- Ready to take challenges in work
- Ready to move to different locations for work as and when required.
- Should be updated with latest regulatory requirements
- 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: 7-8 year
Department: Piramal Critical Care - Regulatory Affairs
Location: Goregaon, Mumbai
Education: B.Pharm or M.Pharm or M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
End Date: 30th June, 2014
In case you wish to apply to this position, please send us your CV
Applications may be sent to research.recruitment@piramal.com.The subject line may read as Application for Manager - Regulatory Affairs -001'
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