Piramal Group Hiring Executive - Regulatory Affairs M. Pharm/B. Pharm/Msc Apply Now
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.
Soft
skills:
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
Qualifications
M.
Pharm/B. Pharm/Msc
Minimum
2 to 3 years relevant experience in handling Europe market. Over all total
experience in Regulatory of 3-5 years
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