Pawan Malode
Officer- Drug Regulatory Affairs at Mylan (Viatris)
- Role
- Officer - Drug Regulatory Affairs at Mylan
- Location
- Nashik, IN
- LinkedIn followers
- 500 followers
About Pawan Malode
Detail-oriented and proactive professional with strong experience in regulatory…
Experience
Officer - Drug Regulatory Affairs
May 2023 — Present
Assisting the ANDA/MAA submissions, lifecycle management of pharmaceutical products, ensuring that regulatory filings and documentation adhered to USFDA and European regulations.• Compilation of documents for regulatory submissions & variation submissions within defined time schedules and in accordance with established standards for submission to regulatory authorities like USFDA & Europe. • Responding to deficiency questions from regulatory bodies and clients, assisting in the preparation of comprehensive answers to ensure smooth approval processes.• Review of technical quality documents required for the submission as well as commercial activities.• Reviewing labelling information, product monographs and marketing materials.• Execution of work procedures in a project context. Providing regulatory technical expertise, support, advice and developing solutions.• Comprehensive knowledge of the eCTD structure & CMC dossier part. • Handling change control software like Trackwise, PDM softwares like Docubridge, MyPortfolio & RIMS.
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