Tushar Mule
Actively looking for opportunity | immediate joiner | |Regulatory Affairs Specialist | CMC,CTD knowledge| ICH M4,M8 quality guidelines.
- Role
- Regulatory Affairs Specialist at Pharmaleaf India Private Limited
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
Experience
Regulatory Affairs Specialist
Pharmaleaf India Private Limited
May 2024 — Present · Bengaluru, IN
I am handling the following activities by using Veeva Vault and CTIS• Responsible for handling submissions including CMCSubmissions CSR, action notifications Label and PIL update.• Creation of Veeva Vault records including events regulatoryobjective, submission objective, activity, HAQ and responsible toupdate the records.• Creation of submission content plan for eCTD including CMC andClinical submission and simple submission in Veeva Vault.• Responsible for uploading documents into submission contentplan for eCTD and simple submission in Veeva Vault.1) Splitting Contact Plan2) Matching Document mode• Collaborating with clinical and CMC team and uploadingdocuments into the Library and naming conventions as per RDNC in Veeva Vault.• Reserving the sequence in tracking table for eCTD submissions.• Responsible to hand over the submission to CRO for publishing• Dispatching the submissions to the respective marketing company• Responsible to take market surveys from respective marketingcompany for specific change.• EU CTR CTIS submissions uploading the documents with details and submitting submission to health authorities.1) Substantial Modification2) CSR Submissions• eTMF QC Check including Crosslinking documents from Veeva vault to veeva clinical vault, running eTMF QC Tool.
Education
Gulabrao patil college of pharmacy,Miraj
Diploma in pharmacy
2015 — 2017
Maharashtra Institute of Pharmacy
B.pharm
2017 — 2020
Shivaji University
Master of Pharmacy
2022 — 2024
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