Aurolab, based in southern part of India, is an integral part of the Aravind Eye Care System. It manufactures a wide range of high quality ophthalmic consumables such as intraocular lenses, surgical sutures, pharmaceutical products, surgical blades and equipments.
Post: Sr. Executive/ Executive Regulatory Affairs
Job Description
- Should have knowledge in eCTD, ASEAN CTD, Nees and country specific regulatory requirements.
Preparing, reviewing & submitting product dossiers on country by country basis.
- Responsible for reviewing API master file & notifying the supplier if any deviations found.
- Responsible for legalization activities like Consularisation, Apostillization etc…
- Monitoring the process of regulatory submissions & ensuring market approvals are granted without undue delay.
- Monitoring and setting timelines for registration variations and renewal approvals in various countries.
- Responding to queries raised by specific regulatory agencies.
- Undertaking and managing regulatory inspections.
- Responsible for maintaining Regulatory Database Management.
- Performing regulatory analysis before entering in to the new market.
Candidate Profile
B. Pharmacy/ M. Pharmacy (Preferred Tamil Nadu and Andhra Candidates)
1 to 3 Years
Additional Information:
Experience: 1-3 years
Qualification: B.Pharm, M.Pharm
Location: Madurai, Tamil Nadu
Functional Area: DRA
Industry Type: Pharma
Employment Type: Full Time
Job Type: Regular
End Date: 30th August, 2015
Intersted candidates send your CV to
Mrs. Swetha
HR Manager
swetha@aurolab.com
Posted by,
Mrs. Swetha
HR Manager
Aurolab
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