Gayathri VARIOR KRISHNAN, PhD, Virology and Immunology, Post Doc, Oncology

+1-908-***-**** adytlu@r.postjobfree.com

Highly trained scientist and experienced educator with excellent communication skills and a wide breadth of knowledge of medical science.

PROFESSIONAL WORK EXPERIENCE

RAPS regulatory affairs dual certification for pharmaceuticals and medical devices, 2023.

Novartis Sandoz, Princeton, NJ March 2023-present

Regulatory Affairs Labeling Associate

Torrent Pharma Inc, Basking Ridge, NJ Oct 2021-Feb 2023

Regulatory Affairs Labeling Associate

●Coordination of labeling projects to ensure regulatory compliance for generics

●Handle regulatory submissions electronically which include new ANDA filings, Information Requests, Complete Response letters, CBE-0, CBE-30 and Prior Approval Supplements (PAS)

●Carry out project deliverables such as initiating, reviewing, and implementing label creation/updates with extreme attention to detail

●Provide regular updates regarding labeling projects to cross functional departments to facilitate coordination for project completion timelines

●Responsible for the creation of pharmaceutical labeling drafts/Final for submission to FDA based on Reference Listed Drug labeling, FDA requirements and client requirements

●Responsible for the creation of labeling in SPL (X-forms) and PLR/PLLR format, using the Pragmatic Validator and doing CDER Direct submissions to the FDA

●Responsible for working with outside vendors for creation of labeling proofs and ensuring accuracy of final labeling

●Responsible for managing and tracking the review process for labeling to ensure timely submissions to FDA

●Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug, USP updates, carving out patents and exclusivities using the Orange book and uploading the labels on the Daily Med and the company website

●Proficient in using the following softwares (Global Vision and Verify, TVT Compare, Workshare Compare) for proof reading of labels, preparing redlines and side by side comparisons of labels

●Initiating and facilitating Change Controls to Graphics, CMC and Operations for smooth submission of updates and changes (both safety and non-safety) for small molecules and biosimilars.

Raritan Valley Community College, Branchburg, NJ 2009-2020

Adjunct Professor

&

Warren County Community College, Washington, NJ 2005-2009

Adjunct Instructor

●Developed scientific and medical education course work for Human Biology, Human Anatomy and Physiology courses (lab and lecture) for students entering health care fields like physicians’ assistant, nursing, exercise science, occupational therapy, and physical therapy

●Communicated complex scientific and medical information using slide decks, visual aids, interactive videos, computer simulations

●Consistently enhanced curriculum and course materials to encompass recent developments in medicine, diseases and treatments

●Consummate multitasker, highly organized team player and focused on timely delivery of results

Chromocell Corporation, North Brunswick, NJ 2013- 2014

Lab Operations Manager

●Managed day-to-day operations in a taste-testing lab

●Drove data analysis and presentation to food scientists and major clients in the agro- food industry

●Supervised 10 to 12 technicians who conducted the taste-testing panels

Ecole Normale Superieure de Lyon, France 1996- 1997

Laboratoire de Biologie Moleculaire et Cellulaire

Post-doctoral fellowship

●Contributed to bringing new insights to the mechanisms of oncogenic transformation of very early hematopoietic progenitors by rearranged retinoic acid receptors. This work led to one publication (ref #8).

EDUCATION

Ecole Normale Superieure de Lyon, France Laboratoire d’Immunobiologie Moleculaire PhD in Molecular Virology and Immunology

1991- 1995

“Characterization of the measles virus receptor, CD 46” This work led to seven publications (ref #1 to 7).

Madurai Kamaraj University, India

M.Sc. (Biotechnology)

1988-1990

Bharathiar University, India

B.Sc. (Biochemistry)

1985-1988

PUBLICATIONS

1.D.Naniche, G.Varior-Krishnan, F.Cervoni, T.F.Wild, B.Rossi, C.Rabourdin-Combe, D.Gerlier (1993) Human Membrane Cofactor Protein (CD46) acts as a cellular receptor for Measles Virus. J.Virol.,67,6025-6032

2.G.Varior-Krishnan, M-C. Trescol-Biemont, D.Naniche, C. Rabourdin-Combe, D.Gerlier (1994) GPI-anchored and transmembrane forms of CD46 display similar Measles Virus receptor properties. J.Virol.,68,7891-7899

3.D.Gerlier, M-C. Trescol-Biemont, G.Varior-Krishnan, D.Naniche, I.Fugier-Vivier, C.Rabourdin-Combe, D.Gerlier (1994) Efficient MHC class II restricted presentation of Measles Virus relies on Haemagglutinin mediated targeting to its cellular receptor Human CD46 expressed by murine cells. J.Exp.Med.,179, 353-358

4.D.Gerlier, M-C. Trescol-Biemont, G.Varior-Krishnan, D.Naniche, I.Fugier-Vivier, C.Rabourdin-Combe, D.Gerlier (1994) Efficient MHC classII presentation of Measles Virus to T cells relies on its targeting to its cellular receptor Human CD46 and involves an endosomal pathway. Cell Biology International., 18, 315-320

5.D.Gerlier, B.Loveland, G.Varior-Krishnan, B.Thorley, I.F.C.MacKenzie, C.Rabourdin- Combe (1994) Measles Virus receptor properties are shared by several CD46 isoforms differing in extracellular regions and cytoplasmic tails. J.Gen.Virol., 75, 2163-2171

6.D.Gerlier, G.Varior-Krishnan, P.Devaux (1995) CD46-mediated measles virus entry-a first key to host range specificity. Trends in Microbiology, 3, 338-345

7.B.Horvat, P.Rivailler, G.Varior-Krishnan, A.Cardoso, D.Gerlier, C.Rabourdin-Combe (1996) Transgenic mice expressing Human Measles Virus (MV) receptor CD46 provide cells exhibiting different permissivities to MV infection. J.Virol, 70, 6673-6681

8.M.Altabef, M.Garcia, G.Varior-Krishnan, J.Samarut (1997) A truncated RARa cooperates with the v-erbB oncogene to transform early haematopoietic progenitors invitro and invivo. Oncogene, 14, 1471-1479

LANGUAGES

•Fluent in English, French, Hindi, Malayalam, Tamil

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