Pooja Telang
Senior Executive-Drug Regulatory Affairs at Novartis
- Role
- Drug Regulatory Affairs-executive at 诺华
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Pooja Telang
Responsible for all DCGI (Health Authority) Submissions-To provide appropriate inputs and ensure submission of New Drug applications for Marketing authorization, line extensions, additional indications and obtain approvals for designated projects-Submission of Clinical Trial applications for Therapeutic areas like Respiratory, Dermatology, Oncology, Rheumatology etc as per the DCGI guidelines-Site registrations and renewals of already existing sites-Query responses for all DCGI queries related to New Drug and clinical trial applications- Test license applications for commercial and clinical trials-Ensuring compliance activities for marketed products like PSUR submission as per local regulations and tracking the same for the submitted PSURs and the future submissions- Maintain SOPs for all regulatory activities and updating them periodically-Responsible for sample CDTL testing for site registrations of the product-Ensuring submissions done to health authority as per CDSCO guidelines and Drugs and Cosmetics Act-Preparation for New Drug Advisory Committee (NDAC) presentations to be presented for approval of Clinical trials and New Drug Applications (NDA).
Experience
Drug Regulatory Affairs-executive
Sep 2010 — Present
Education
NDMVP College Of Pharmacy
Bachelor in Pharmacy
2004 — 2008
World Intellectual Property Rights (WIPO)
On line course on Intellectual Property Rights
2008 — 2009
Principal K.K.Kundnani College of Pharmacy
Master's degree, Pharmacology and Toxicology
2008 — 2010
Skills
- Technology Transfer
- Ich-Gcp
- Pharmacovigilance
- Regulatory Submissions
- Drug Delivery
- Medical Affairs
- Clinical Development
- Formulation
- Pharmaceutics
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.