Benjamin Franklin
Associate Regulatory Manager
- Role
- Associate Regulatory Manager at Novartis India
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Benjamin Franklin
10+ years\' experience in projects supporting new product launch, manufacturing production transfer & support for samples required for HA for drug regulatory submissions and Regulatory CMC, filing submissions for EU variations
Experience
Associate Regulatory Manager
Sep 2022 — Present · Hyderabad, IN
Handle new product launch in countries and fulfill requirements of Certificates and samples required by HA facilitating local RA team at country level with regulatory submissions to be done on time - Project management handling country requirements related to new product launch- Handle manufacturing production transfer in countries and fulfill requirements of Certificates and samples required by HA facilitating local RA team at country level with regulatory submissions to be done on time - Project management handling country requirements related to manufacturing production transfer- Planning drug regulatory samples for HA submissions throughout the product life cycle- Coordinate different stakeholders like supply chain, country specific pharma office, regulatory managers and associates to deliver samples within timelines- Provide support for different kinds of regulatory samples like finished product, drug substance, reference standard etc- Solve problems related to availability of required regulatory samples, storage and shipment conditions, coordinating with assigned warehouse for dispatch of samples
Education
Malla Reddy College of Pharmacy, Osmania University
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2007 — 2011
Masters in Regulatory Affairs & Drug Development, Alliance Institute, JNTUH
Master's degree, Drug Development and Regulatory Affairs
2011 — 2013
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