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
Product line:-
Sterile Pharmaceuticals [Eye Drops, Injections…] & Medical Devices [IOLs, Sutures ….]
Region:-
Emerging Markets (ROW Markets) - Africa, Southeast Asia, LATAM, Eastern Mediterranean, SAARC
Roles & Responsibilities
- 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.
- Ensuring timely management of manufacturing license variations and renewals including CoPP, FSC, GMP etc...
- 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
Prefer B. Pharm Cader, M. Pharm can also apply
Exp: 1 to 3 years
Additional Information:
Experience: 1-3 years
Qualification: B.Pharm, M.Pharm
Location: Madurai, TN
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.comKrishna Kumar
Senior Regulatory Affairs Manager
krishna@aurolab.com
Posted by,
Mrs. Swetha
HR Manager
Auro Lab
See All D.Pharm Alerts B.Pharm Alerts Ahmedabad Alerts Gujarat Alerts
See All Other Jobs in our Database
.png)
