Ashwini Patil-Babar
🏅Gold Medalist🏅#Masters in pharmaceuticals#Regulatory Affairs Manager at PLG#Ex-Cipla#EX-Genpact
- Role
- Regulatory Affairs Manager at ProductLife Group
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Ashwini Patil-Babar
To work for a professionally managed organization and help in its growth, which offers me an opportunity to enhance my skills with a sense of accomplishment & satisfaction. To be an asset by applying my skills acquired during the course of education along with the learning experiences in the field I am associated with. With that, contributing the best of my ability, hard work and sincerity to my field of interest towards achieving the organizational goal as well as professional goal
Experience
Regulatory Affairs Manager
Oct 2024 — Present · IN
Responsible for MA transfers and maintaining product history as per defined timelines and processes.Author high-quality CMC documentation (dossiers) for health authority submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.• Experience of work sharing and super grouping variations submissions. Prepare CMC responses to health authority questions during development, registration and product lifecycle. Regulatory evaluation of change controls and various other quality events (e.g. Deviations, OOS/OOT/OOE etc.) for possible regulatory impact. • Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Experience of managing QP declarations, GMP certificates, CEPs, Import permissions, COPP, legalizations, Apostille, translations, sample management as per global regulatory requirement• Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
Education
Vivekanand Education Societys College of Pharmacy Sindhi Society Chembur Mumbai 400 071
Masters in pharmacy, Pharmaceutics and Drug Design
2012 — 2014
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