Onkar Joshi
Executive Regulatory Affairs
- Role
- Regulatory Affairs Associate at Fresenius Kabi
- Location
- Gurugram, IN
- LinkedIn followers
- 500 followers
About Onkar Joshi
A highly passionate regulatory professional with experience in regulatory publishing…
Experience
Regulatory Affairs Associate
Jan 2024 — Present · Gurugram, IN
Expertise in eCTD Compilation and Regulatory Submissions:1. Conduct an initial review of the technical documents As- Raw material specification, Finishproduct specification, BMR, PDR, Analytical Method validation, Stability study protocol/ report,Process validation protocol, and report.2. Post-Approval Documents Preparation, Compilation, and Publishing: Proficient in thepreparation, Compilation, Publishing, and review of post-approval submissions, including AnnualReports, CBE-0 (Changes Being Effected), CBE-30, PAS (Prior Approval Supplement), and PADER(Periodic Adverse Drug Experience Report).3. Publishing and Submission Management: Expertise in managing the entire publishing process andsubmission management to ensure timely and accurate dossier/supplement submissions.4. Project Oversight: Capable of overseeing all activities related to eCTD submissions, withaccountability for meeting project-assigned deliverables.5. Regulatory Operations Support: Provides support to Regulatory Operations as needed, assistingwith various tasks and challenges.
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