Established in the year 1924 in India GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 3500 people. Globally, we are a £ 26.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders with a turnover of Rs. 3021 crore and a share of 4.2%*. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.
Post: Assistant Manager Regulatory Affairs ( 5 yrs of experience)
Job Description:
1.Responsible for fulfilling regulatory responsibilities for activities related to registration of new drugs and lifecycle management of existing products for chemical entities, biologicals and vaccines in domestic markets.
2.Compile Regulatory Dossiers for submission to Central Drugs Standards Organization (CDSCO)
3.Track and maintain the product lifecycle to ensure all licenses are renewed prior to expiry.
4.Liaise with International Regulatory group for documentation and other regulatory requirements.
5.Ensure regulatory compliance to requirements of Drugs and Cosmetics Act for GSK products approved by DCGI.
Candidate Profile:
Candidate must possess at least a Master of Science/ Bachelor in Pharmacy.
At least 5 year(s) of working experience in the related field is required for this position.
Preferably Senior Executives specializing in Regulatory Affairs.
1 Full-Time position(s) available.
Additional Information
Experience: Min.5 Years
Qualification: M.Sc, B.Pharm
Functional Area: R&D
Location: Mumbai
Last Date: 10th Aug. 2013
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