Samiksha Kulkarni Email & Phone Number
Who is Samiksha Kulkarni? Overview
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Samiksha Kulkarni is listed as Regulatory Affairs Intern at TG Therapeutics | Grad student at Northeastern University at TG Therapeutics, Inc., a company with 189 employees, based in Boston, Massachusetts, United States. AeroLeads shows a matched LinkedIn profile for Samiksha Kulkarni.
Samiksha Kulkarni previously worked as Regulatory Affairs and Quality at Tg Therapeutics, Inc. and Regulatory Associate Intern at Evon Medics, Llc. Samiksha Kulkarni holds Masters In Regulatory Affairs from Northeastern University.
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About Samiksha Kulkarni
I am currently pursuing Master’s in Regulatory Affairs from Northeastern University, Boston. My passion lies in the healthcare industry and I am eager to apply my knowledge and skills to help bring innovative and safe medical products to market. With a strong understanding of regulatory requirements and a keen attention to detail, I am confident in my ability to navigate the complex world of healthcare regulation. I am excited to begin my career in the industry and gain the practical experience necessary to excel in this field.Skillset:• Strong knowledge of regulatory guidelines (ICH, FDA, EMA)• IND, NDA, BLA• Common Technical Document (CTD)/ eCTD• 21 CFRs, cGMP, GLP, GCP• CMC (Chemistry manufacturing controls)• Medical Device Regulations (PMA, 510K, ISO 13485)• Quality Management System (QMS)• Experience in navigating Federal Register, FDA Guidance, ClinicalTrials.gov, Medical Device
Samiksha Kulkarni's current company
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Samiksha Kulkarni work experience
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Regulatory Associate Intern
Rso Proctor
Medical Writer
- Conducted literature reviews and organized data for regulatory submissions and product development across various therapeutic areas.
- Authored PILs and SPCs for pharmaceutical products, ensuring accurate and comprehensive information, and developed healthcare blogs to educate and raise awareness on medical topics.
- Drafted case studies highlighting successful patient outcomes and treatment efficacy.
- Summarized key findings from various health conferences, distilling complex scientific information into concise summaries.
- Assisted in the preparation of responses to regulatory queries and requests for information, addressing any medical writing-related concerns.
Colleagues at TG Therapeutics, Inc.
Other employees you can reach at tgtherapeutics.com. View company contacts for 189 employees →
Charlotte He
Colleague at Tg Therapeutics, Inc.
Lexington, Massachusetts, United States, United States
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PH
Patricia Holoman
Colleague at Tg Therapeutics, Inc.
Raleigh, North Carolina, United States, United States
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SE
Sheri Ellis, Rn, Bsn, Mscn
Colleague at Tg Therapeutics, Inc.
Charlotte Metro, United States
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MV
Marisa Valentinetti
Colleague at Tg Therapeutics, Inc.
Eatontown, New Jersey, United States, United States
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CR
Charlie Robison
Colleague at Tg Therapeutics, Inc.
Kennesaw, Georgia, United States, United States
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AP
Amy Prins
Colleague at Tg Therapeutics, Inc.
Novi, Michigan, United States, United States
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MK
Michele Kosnik
Colleague at Tg Therapeutics, Inc.
Buffalo-Niagara Falls Area, United States
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NN
Nguyen Ngan Kim
Colleague at Tg Therapeutics, Inc.
Vietnam, Viet Nam
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BW
Brandy Whittington
Colleague at Tg Therapeutics, Inc.
Mount Pleasant, South Carolina, United States, United States
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CD
Christopher D Casperson
Colleague at Tg Therapeutics, Inc.
Singapore, Singapore, Singapore
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Samiksha Kulkarni education
Masters In Regulatory Affairs
Post Graduate Diploma, Regulatory Affairs
Bachelor Of Pharmacy - Bpharm, Pharmacy
Frequently asked questions about Samiksha Kulkarni
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What company does Samiksha Kulkarni work for?
Samiksha Kulkarni works for TG Therapeutics, Inc..
What is Samiksha Kulkarni's role at TG Therapeutics, Inc.?
Samiksha Kulkarni is listed as Regulatory Affairs Intern at TG Therapeutics | Grad student at Northeastern University at TG Therapeutics, Inc..
Where is Samiksha Kulkarni based?
Samiksha Kulkarni is based in Boston, Massachusetts, United States while working with TG Therapeutics, Inc..
What companies has Samiksha Kulkarni worked for?
Samiksha Kulkarni has worked for Tg Therapeutics, Inc., Evon Medics, Llc, Northeastern University, and Spellbound Inc..
Who are Samiksha Kulkarni's colleagues at TG Therapeutics, Inc.?
Samiksha Kulkarni's colleagues at TG Therapeutics, Inc. include Charlotte He, Patricia Holoman, Sheri Ellis, Rn, Bsn, Mscn, Marisa Valentinetti, and Charlie Robison.
How can I contact Samiksha Kulkarni?
You can use AeroLeads to view verified contact signals for Samiksha Kulkarni at TG Therapeutics, Inc., including work email, phone, and LinkedIn data when available.
What schools did Samiksha Kulkarni attend?
Samiksha Kulkarni holds Masters In Regulatory Affairs from Northeastern University.
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