Shivani Jadhav
Regulatory Affairs Officer at Medley Pharmaceuticals Ltd
- Role
- Regulatory Affairs Officer at Medley Pharmaceuticals Ltd
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Shivani Jadhav
Working as a regulatory affairs professional since 5 years with experience of working for Europe and UK market • Proficient in eCTD dossier (Module 1 to Module 5) preparation, compilation and submission to MHRA regulatory authority as per MHRA and EU guidelines • Expertise in analyzing and reviewing study protocols and reports like Analytical Method Validation, Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), Specification, Analytical Procedures, packaging documents and Stability studies • Proficient in coordinating and communicating with QA, ADL and RnD team regarding to ensure compliance of study reports with ICH and regulatory guidelines and providing regulatory inputs • Worked on preparing Summary of Product Characteristics, Patient Information Leaflet (PIL) and artworks of carton and label • Expertise in life cycle management of regulatory submissions and responding to queries raised by regulatory authorities • Well versed with Module 1 to Module 5 submission on eCTD publishing tools like Pharma Ready • Good understanding of drug development process, EU and UK regulations and ICH guidelines
Experience
Regulatory Affairs Officer
Mar 2021 — Present · IN
My role as a regulatory affairs officer involves working on documents required for eCTD dossier preparation (Module 1 to 5) and checking if they are compliant for regulatory submission to UK-MHRA, compilation and submission of dossier, analysing study reports (Analytical Method Validation, Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), Specification, Analytical Procedures, Packaging Documents, Stability Studies), preparing patient information leaflet and reviewing artworks of carton and label
Education
Institute of Good Manufacturing Practices India (IGMPI)
Post graduate diploma, Drug regulatory affairs, A
2019 — 2020
Dr.Bhanuben Nanavati College of Pharmacy
Master of Quality Assurance, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs, A
2015 — 2017
H.K.College of Pharmacy
Bachelor of Pharmacy - BPharm, Pharmacy
2011 — 2015
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