Vinutha S
Regulatory professional II at Novo Nordisk
- Role
- Regulatory Professional Ii at Novo Nordisk
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Vinutha S
Global Regulatory Affairs Specialist with 7 years of experience in Regulatory Operations,…
Experience
Regulatory Professional Ii
Apr 2024 — Present · Bangalore, IN
Responsible for end-to-end publishing and submission of regulatory dossiers (initial MAA & LCM) across EU (NP, MRP/DCP/CP), UK, Swiss, GCC, ROW, and Australia.2. Experienced in preparing eCTD and NeeS dossiers, ensuring compliance with regional and ICH standards.3. Skilled in Veeva Vault, ISI Toolbox, and Lorenz eValidator for publishing and validation.4. Lead work-sharing and super-grouping submissions to improve efficiency and consistency.5. Collaborate with CMC, labeling, and product teams to meet submission timelines and quality standards.6. Stay updated on regulatory guidelines and share best practices to drive continuous improvement.
Education
BMS College for Women, Bangalore
Bachelor of Science, Biotechnology
2013 — 2016
PES UNIVERSITY, BANGLORE
PUC, PCMB
St. Aloysius College (Autonomous), Mangalore
Master of Science, Biochemistry
2016 — 2018
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