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Regulatory Affairs Specialist

1.00 to 6.00 Years   Vijayawada   16 Sep, 2024
SPENTO PAPERS (INDIA) LLP
Job LocationVijayawada
EducationNot Mentioned
SalaryRs 4.0 - 9 Lakh/Yr
IndustryPharma / Biotech
Functional AreaPharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

    Provide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentation Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals) Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines Act as liaison between multiple project teams to obtain significant information as well as answer queries that may arise Communicate design changes to existing products and company practices where necessary Plan and develop product trials and interpret trial data, as well as take part in marketing activities for packaging or advertising approvals Stay up to date with the latest rules and regulations Give presentations to regulatory authorities

Keyskills :
qualitymanagementproblemregulatorycommunicationassurancethinkingorientedprojectskillssolvingsubmissionsdetailcriticaldevicemedical

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