Full Time

Hyderabad

Posted 6 hours 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