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வெற்றி என்பது உன்னை உலகத்திற்கு அறிமுகம் செய்வது.... தோல்வி என்பது உன்னை உனக்கே அறிமுகம் செய்வது !!!

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Thursday, March 22, 2012

AM/Manager(Europe Market)


The sender of this email is registered with Naukri.com as Elance Group
Experience required for the Job: 5 - 15 years
Annual Salary of the Job: 6.0 - 8.0 Lacs
Job Location: Gurgaon

Apply Now(Send your Naukri profile to express interest to the recruiter)


Dear Candidate,

We would like to introduce Elance Group as leading HR consultancy. We have an opportunity for Research Scientist with a leading Pharma company. Kindly mail us your updated resume at elancegroup@consultant.com or call at 0522-4153666/09235614230 between 10am - 6pm.

Key Responsibility :

* Must have thorough understanding of EU and Emerging Market (Brazil, Mexico, Russia, South Africa, GCC, Turkey) regulations governing pharmaceutical products. Understanding of the PMDA, Japan requirements will be an added advantage.
* Careful delegation of tasks whilst maintaining responsibility for final result
* Careful planning to achieve accurate and timely results
* Ability to discuss strategic and sensitive issues
* Recognise recurring issues and analyse their causes in order to reach a solution
* Manage all aspects of the regulatory process for EU and Emerging Market submissions, viz, review and submission of the marketing authorization application, timely and satisfactory response during the entire procedure
* To prepare and co-ordinate the submission of variations, renewals, PSURs etc.
* Manage a team that consists of 2-3 regulatory affairs personnel
* Participate in product teams with regard to implementation of regulatory requirements
* Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
* Provide regulatory expertise to analytical and formulation development teams and ensure that information is interpreted correctly
* Review of the technology transfer documents with regards to EU and Emerging Market requirements
* Handling of change controls
* Maintain a working knowledge of regulatory requirements and guidelines and communicating changes in regulatory information to the team members
* Flexibility to work for different regions, based on internal requirements, if required.
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Disclaimer:
The sender of this email is registered with naukri.com as Elance Group (careers@elancegroup.com, 11-12, Green Wood Apartment, 22 Gokhle Marg, LUCKNOW, Uttar Pradesh - 226001) using Naukri.com services. The responsibility of checking the authenticity of offers/correspondence lies with you.

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