Pooja Tirthani
Domain Specialist @Tata Consultancy Services
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WORK HISTORY
Domain Specialist @Tata Consultancy Services
Mumbai, IN
Submission and Publishing of different submissions for global market like EU, GCC, and ROW countries includes Initial submissions, Variations (Type IA, IB, II), Supplemental Information, Responses, Consolidation/Invalidation, Renewals and Baseline according to country\'s requirement i.e eCTD or Nees.2. Fixing eCTD validation related issues in eCTDXPress.3. To create new eCTD applications, fill correct metadata both ICH and Regional as per alignments.4. To Assign Administrative and Regulatory documents in eCTDXPress as per module specified.5. To perform correct naming convention as per ICH naming convention for eCTD.6. To perform compilation of sequences, get published output, and perform final validation checks using Lorenz eValidator.7. To perform submission dispatch activity includes email dispatch and ESG gateway for US submission.8. To communicate with requesters, LOCs and HA, for any submission related queries.9. To perform archiving activities for eCTD sequences, Core packages and HA communications emails
EDUCATION
B.K.Modi Government Pharmacy College
Bachelor's Degree, Pharmacy
Saraswati institute of pharmaceutical science
M.Pharma , Quality assurance
BIOINFROMATICS INSTITUTE OF INDIA
Diploma in Regulatory Affairs , Regulatory Affairs
SKILLS
ABOUT POOJA TIRTHANI
10 years experience in the core regulatory & publishing role. Handling BLA,NDA, major MAA submissions, Trouble shooter & Trainer
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