Rohini Zalse
Regulatory Affairs | eCTD | Submission Publishing | Dossier Preparation | Document Migration | Veeva Vault | RIM | Mpharm
- Role
- Regulatory Affairs Consultant at ADVANZ PHARMA
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Rohini Zalse
Software - eCTD Manager (extedo)- Veeva vault - ISI toolbox - Supporting Regulatory function by performing Publishing activities for all market (UK, IE, EU, ROW, GCC, ANZ)- Ensuring global eCTD and submission meet the required external and internal quality standards- Post approval activity- Review approval notification received from HA- Master data creation and management in RIMS- Data migration activity - Provide support to the line manager for projects such as XEVMPD, Regulatory information management and IDMP
Experience
Regulatory Affairs Consultant
Jul 2023 — Present · Mumbai, IN
Education
MVP Samaj's College of Pharmacy, Nashik
Master of pharmacy, Pharmaceutical Quality Assurance
2021 — 2022
R G Sapkal college of pharmacy Nashik
Savitribai phule pune university Bachelor of Pharmacy
2016 — 2020
MVP Samaj's College of Pharmacy, Nashik
Diploma in Drug Regulatory Affairs
2021 — 2022
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