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Technical Associate - Regulatory Affairs

1.00 to 4.00 Years   Mumbai City   28 Jul, 2022
Genpact India Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaCustomer Service (International)Sales / BD
EmploymentTypeFull-time

Job Description

    Technical Associate, Regulatory affairs.In this role, you will be expected to work on deadlines, in a fairly high pressure business environment while being a good great teammate. Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Responsibilities: Liaise with key interfaces on project requirements to ensure timelines are mutually understood. Drafting responses to MAH for Health Authority queries. Identify discrepancies/issues in local implementation of corporate labels. Lead team for timely deliverables. Monitor reference labels (from up to three countries) for updates and ability to connect with concerned affiliates directly using Sanofi communication/collaboration tools. Maintaining updates related to labeling guidelines and regulations as they pertain to the development/maintenance of CCDS, US, EU and ROW labeling. Qualifications we seek in you Minimum qualifications Masters in Lifesciences or equivalent with proven experience in regulatory Affairs/Labeling or equivalent Knowledge of the principles and concepts of Labeling Ability to identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions Must be able to construct a Company Response (MAH response) for health authority questions Preferred qualifications Excellent communication and PC skills,

Keyskills :
sqljavacustomer relationstroubleshootingdatabase administrationlife scienceshigh pressurecustomer focusccdsvisitcolorlabels

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