Full Time
Hyderabad
Posted 2 weeks ago

To ensure that the below-listed tasks should be done carefully for a successful submission, and approval of the assigned products.

  • Reviewing of the DS part of the dossier for the US, EU, and ROW.
  • Reviewing of SFDA templates and compiled a dossier of Drug Substances.
  • Reviewing of e-Functionalities and eCTD published dossiers.
  • Level-2 review of Analytical method validations.
  • DMF review and gap sheet release for US, EU, and ROW.
  • Preparation of Query responses and client responses.
  • Archival of master data and emails received from respective clients.
  • Review of Product History Sheet & management of the data in the server of the respective projects.
  • Updated guidelines review.
  • Self-training and improvement.

PRINCIPAL ACCOUNTABILITIES

Accountabilities Major Activities Key Performance Indicators
  • Review of the DS part of the dossier for the US, EU, and ROW.
  •     Review of Drug substance-related modules in the dossier for the US, and ROW.
  •  Ensure timely closure of assigned activities and accuracy in the work
  • Reviewing of SFDA templates and compiled a dossier of Drug Substances.
  • Final review of SFDA templates and compiled dossier for Saudi with respect to the drug substance.
  • Ensure timely closure of assigned activities and accuracy in the work
  • Reviewing of e-Functionalities and eCTD published dossiers
  •  Final review of e-functionality check and published dossiers with respect to the drug substance.
  • Ensure timely closure of assigned activities and accuracy in the work
  • Level-2 review of Analytical method validations.
  • Review of drug substance validations for both DSM and DPM sites.
  • Ensure timely closure of assigned activities and accuracy in the work
  • DMF review and gap sheet release for US, EU, and ROW.
  • Base DMF review and gap sheet preparation/updates for US, EU, and ROW.
  • Ensure timely closure of assigned activities and accuracy in the work
  • Preparation of Query responses and client responses.
  • Preparation of action items against queries received from the agency and releasing of responses to clients.
  • Ensure timely closure of assigned activities and accuracy in the work
  • Archival of master data and emails received from respective clients.
  • Doing archival on daily basis for assigned projects within folders as per SOPs and review of monthly archival reports.
  • Accuracy in the Archival

SKILLS AND KNOWLEDGE

Educational Qualifications
M.Sc Biotechnology

Functional Skills

  • Team management
  • Collaborative working skills
  • Trainings for within the team and CFT

Relevant and total years of Experience

6.5 Years

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