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Officer/Assistant- Product Registration

1.00 to 3.00 Years   Kolkata   18 May, 2022
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

    • Preparation, compilation and development of data for ROW & Semi Regulated Market
    • Should be well informed about CTD, ACTD & country specific guidelines.
    • To interact with various departments/teams to collect documents required for dossier compilation on time as per regulatory norms
    • Review of the quality and analytical data as per the Pharmacopoeia, Specification, Method validation, Batch manufacturing records, Stability, Finished product / Packaging material data for the purpose of compilation of the dossier
    • Reviewing and Managing applications for License, COPP, FSC and DMF
    • Responding to technical queries related to product registration
    • Ability to work as a member of team to achieve all targets within time
    • Ability to contribute to the creation and promotion of an environment of teamwork
    • Should be efficient in keeping good relationship with International Customers
    • Required Good communication skills
    • Age range preferred: Not above 30 years
    Desired Candidate Profile:Education: UG: Any graduation (B Pharma preferred)Experience: 1-3 yearsCandidates having good computer skills and aggressive with go-getter attitude to drive the business. If you are interested, kindly forward your resume on hidden_email along with the passport sized photograph.,

Keyskills :
regulatorymethod validationcontinuous improvement facilitationanalyticalborder controlcompilationcomputer skillsvalidation

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