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Senior Executive Regulatory Affairs

4.00 to 7.00 Years   Hyderabad   17 Dec, 2021
Aizant
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD,Corporate Legal Department
EmploymentTypeFull-time

Job Description

Roles and Responsibilities

  • Responsible for preparation and compilation of the dossiers in CTD/eCTD and other formats as required for submission to different regulatory authorities.
  • Review the documents i.e Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc.
  • Preparation of query response for submitted applications received from various regulatory authorities.
  • Responsible for life-cycle management of regulatory submissions.
  • Responsible for preparation and maintenance of all the documents related to the regulatory submissions.
  • Coordinate and supports all concerned departments with respect to the required documents for submission purpose.
  • Responsible for review of change controls and checking for regulatory compliance for all documents.
Training the line function in updating the current guidelines and requirements. Interested candidates can share their updated CVs to careers@aizant.com with subject line as Regulatory affairs US market Only the profiles matching the above job description criteria will be scheduled for Telephonic /Personal Interview *Candidates from formulation division will be considered.,

Keyskills :
recordsprofilesstability protocolbudgetingapimatchingregulatorycompliancebusiness developmentcommunication skillsstpprotocolcvsdmfmaintenancebusiness case analysisbatch recordsprotocolsregulatory compliancemanagement

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