P Sunil Prusty
Regulatory Affairs Officer | Viatris | Master of Pharmacy
- Role
- Regulatory Affairs Officer at Viatris
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About P Sunil Prusty
As a Regulatory Affairs Officer at Viatris, I\'ve honed my expertise in managing…
Experience
Regulatory Affairs Officer
Apr 2023 — Present · Hyderabad, IN
EU Post-Approval CMC changes & Life cycle management• Preparation and compilation of CMC related variation packages (Type IAIN, Type IA, Type IB and Type II)• Address answers and different observations raised by Regulatory Agencies to ensure compliance.• Evaluate change controls to confirm consistency between registered and proposed information as raised by the site quality team, in order to maintain lifecycle of pharmaceutical products.• Provide regulatory expertise to cross-functional teams and facilitate coordination to meet post-approval product requirements.• Upload variation packages via Documentum to support publishing activities.• Review and assess technical documents necessary for variation submission.• Evaluate commercial stability protocols to ensure adherence to regulatory standards and alignment with current registered information.• Utilize software tools including Documentum, DocuBridge, and TrackWise for regulatory compliance and documentation.• Prepare and compile license particulars to maintain registered information for internal reference.• Manage internal and external communications by using Outlook mail and Microsoft Teams to ensure effective collaboration.
Education
College of Pharmaceutical Sciences (CPS), Mohuda, Berhampur
Bachelor of Pharmacy - BPharm
2015 — 2019
Indira Gandhi Institute of Pharmaceutical Sciences (IGIPS), Bhubaneswar
Master of Pharmacy
2020 — 2022
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