Vacancy for Associate Manager in Regulatory Affairs at Merck
Our businesses in U.S. and Canada operate as EMD Serono in Biopharma, MilliporeSigma in life science and EMD Performance Materials in the chemicals and high-tech materials business. Outside of the U.S. and Canada, we hold the rights to the name and the trademark “MERCK”. The businesses of Merck KGaA, Darmstadt, Germany are truly global, with 52,000 employees in 66 countries working on breakthrough solutions and technology.
Post : Associate manager / Manager RA
• To handle preparation/compilation and submission of all activities (New drug approvals / CT/ registrations/ renewals/ Import licence/ device related/Test Licences/Query Responses/Post Approval changes) related to all imported products registered
• To Create/Review/Update and Approve artworks in D2 artwork system management.
• To Review/Approve/Upload Trackwise database requests
• To Review/Update Regulatory Information Management System (RIMS) database and other Databases and Computer applications for all imported products
• Regulatory support to other regulatory tasks
KEY TASKS & RESPONSIBILITIES :
• Marketing approval, Registration, Import License, Renewals, Clinical Trail approval, Device related, Post Approval Change, Amendment and Query Response applications including maintenance of the licences.
• Work on drugs/biologicals/Food / Devices
• SUGAM experience
• Update/Maintain records/Trackers
• Creation/review/approval / updation of artworks
• Create/Review/Update Trackwise and RIMS Databases
• Follow-up with the Health Authority and the Liasoning agent on the submissions made.
• Science / Pharmacy Graduate
• Experience of minimum 3-5 years in Regulatory Affairs
• Knowledge of regulations and ability to comply with them
• Can work independently in a multifunctional environment,
• High motivation for self-training on regulatory related frame, e.g. legislations and procedures
• Negotiating skills with other local functions, ability to create and maintain strong and trustful relationship with corporate groups proactively, total professional integrity.
• Adaptable and a Team Worker
Experience : 3-5 years
Qualification : B.Pharm, B.Sc
Location : Mumbai, Maharashtra
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 25th August, 2018
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