Sai Yashwanth
Global Regulatory Operations: RIMS/ Regulatory Data Management/ Structured Data Submissions/ xEVMPD Submissions/ IDMP/ PLM/ SPOR
- Role
- Senior Associate at Freyr Solutions
- Location
- Visakhapatnam, AP, IN
- LinkedIn followers
- 500 followers
About Sai Yashwanth
I\'m Sai Yashwanth completed my M.Pharmacy in Pharmaceutical Technology (ANDHRA…
Experience
Senior Associate
Jul 2025 — Present · Hyderabad, IN
Subject Matter Expert on xEVMPD (Article 57) Submissions, IDMP, Structured Data Submissions and European regulatory framework including SmPC, PIL and CMC Documentation (Module 3).• Perform xEVMPD submissions to ensure compliance via EVWEB.• Expertise in handling SMS, OMS and RMS requests in SPOR portal.• Support in PSMF Annex to align MAH as per xEVMPD.• Support ESMP Activity for identification and management of shortages, as well as improved communication between EMA, national competent authorities (NCAs) and industry stakeholders to ensure medicine availability for patients during public health emergencies and major events.• Perform review of PSUSA Line listing and additional requests.• Handling MA transfer as per HA requirements.• Manage interactions and collaboration with RA Country Strategist on regulatory and Compliance maintenance activities for Authorized medicinal products and Investigational medicinal products.• Optimally support QPPV and PV – relevant processes (Incl. Annual PV fees).• Provide support for internal/ external Audits as needed.• Provided crucial support to Regulatory Affairs teams by ensuring the Documents Management System remained Effective.• Compile, verify accuracy, and sort regulatory license information for products identified for withdrawal.• Managed document-level publishing for EU initial Marketing Authorization (MA) and lifecycle activities with RIMS (DRAGON, REDIGO) • Handling Post submission queries raised by HA and Serves as regulatory liaison throughout product lifecycle.• Perform coding of the Clinical Particulars attributes (Indication, Co- morbidity using MedDRA dictionary as required to ensure xEVMPD/IDMP requirement.• Ensure data quality and exchange with EMA including analysis and tracking 3rd Acknowledgements.
Education
VIJNANA VIHARA RESIDENTIAL SCHOOL
CBSE
2007 — 2013
Andhra University
M PHARMACY
2019 — 2021
Raghu College Of Pharmacy
Bachelor of Pharmacy - BPharm
2015 — 2019
Sri Chaitanya College of Education
Intermediate
2013 — 2015
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.