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Regulatory Affairs Officer

1.00 to 5.00 Years   Ahmedabad   05 Jul, 2023
NIRIT ENTERPRISE
Job LocationAhmedabad
EducationNot Mentioned
SalaryRs 1.0 - 4.0 Lakh/Yr
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    Dear Sir/Maam,Roles and ResponsibilitiesA) To review dossier prepared by executives and trainees and submit to client along with artworks for countries like ASIA, LATAM & ROW Market.B) To work on Renewals of Registration Certificate for countries.C) Ensure that a companys products comply as per current ICH and Country Guidelines. D) Courier of Legalized Documents such as COPP, FSC, POA, ManufacturingAgreement, Declaration letters for updation of artworks, GMP certificate to respective clients and countries.E) Courier of Samples for New registration and Renewal Purpose as per client requirements for reanalysis and first commercial batch analysis purpose.F) Arrangement of Sample and Legals required as per new registration and Renewal purpose from Legal team, Production department and FRD.G) Follow up with FRD and Microbiology department for test requirements by client on batch FPCOA.H) Arrangement and courier of Working Standards from QC department to Client or country as required for testing purpose.I) Resolving queries from client regarding new registration and renewals as per country requirements.J) Updation and maintenance of Country Specific Global Status sheets for New registration, Renewals and Query Status.K) Follow up for Review and corrections of Artworks required for New registration and Renewals with Artwork department as per client and company requirements.L) Follow up and arrangements of Documents required for Dossier Preparation with QA, QC, ARD and Micro Department as per country guidelines.

Keyskills :
regulatory intelligencedossier preparationregulatory submissionsregulatory interactionsregulatory affairs

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