Himgauri Naik

FAQ About Himgauri Naik

• What is Himgauri Naik's address?

  Himgauri Naik is located at
  Greater Orlando, Greater Orlando, United States

• What is Himgauri Naik's job title?

  Himgauri Naik is a
  Self-directed Ph.D with a deep history of Regulatory Affairs as well as a background in research, medical writing, and project management. Equipped with years of experience as a regulatory Affairs Specialist at Immunovant, clinical trials background at Immunovant, am a US Regulatory Affairs Strategy Certification in biologics/small molecules. Equipped with research expertise in oncology drug development (HER2 +ve Breast and Lung Cancer), and Neuroscience (Alzheimer’s disease). Excellent interpersonal and communication skills and works effectively in collaborative, cross-functional team dynamics. Fast learner, innovative thinker, and a team player who can adapt and support overall company goals. Certified in US regulatory affairs and compliance. Strong understanding of the clinical trial process (IND, BLA, NDA) as well as the various module components of electronic common technical document (eCTD) system for FDA regulatory submissions. Developed understanding of key critical regulatory strategy based submissions factoring into various phases of development (IND phase 1-3) including the IND submissions, DSURs, Investigational brochures, Protocols, Protocol Amendments, ICFs, and expedited pathway submissions (Fast track, Breakthrough, Priority). KEY COMPETENCIES: ▸ eCTD Modules 1,2,3,4,5 Understanding ▸ ICH, CFR, GCP ▸ FDA Meeting Preparation / Execution ▸ Annual Reports (ODD/DSUR) ▸ Drafting IND, NDA, BLA Submissions ▸ Medical Writing ▸ Project Management ► REGULATORY BACKGROUND •Increased knowledge of regulatory requirements and strategies for documents needed for product approval and lifecycle maintenance (INDs, NDAs, BLAs, amendments, supplements, annual reports, and license renewals). •Enhanced understanding of the regulatory filing process including the eCTD module 1,2,3,4,5 structure systems. •Enhanced knowledge in both regulatory and compliance issues related to publications, clinical trials, and drug development. •Results driven regulatory professional with an experience in regulatory submission review, regulatory intelligence & strategy for development of FcRn targeted monoclonal antibody. •Goal oriented and innovative scientist having 5+ years of experience with an expertise in oncology drug discovery, and drug development, and nanoparticle formulation development. •Knowledgeable and understanding of clinical trials process including information about clinical endpoints, population enrolled, data collection, adverse event incident, and statistically relevant results report. ► HOW YOU CAN CONTACT ME [email protected] Immunovant

• What industry does Himgauri Naik currently work in?

  Himgauri Naik currently works in the
  Immunovant

• What is Himgauri Naik's area of expertise?

  Himgauri Naik specializes in
  Self-directed Ph.D with a deep history of Regulatory Affairs as well as a background in research, medical writing, and project management. Equipped with years of experience as a regulatory Affairs Specialist at Immunovant, clinical trials background at Immunovant, am a US Regulatory Affairs Strategy Certification in biologics/small molecules. Equipped with research expertise in oncology drug development (HER2 +ve Breast and Lung Cancer), and Neuroscience (Alzheimer’s disease). Excellent interpersonal and communication skills and works effectively in collaborative, cross-functional team dynamics. Fast learner, innovative thinker, and a team player who can adapt and support overall company goals. Certified in US regulatory affairs and compliance. Strong understanding of the clinical trial process (IND, BLA, NDA) as well as the various module components of electronic common technical document (eCTD) system for FDA regulatory submissions. Developed understanding of key critical regulatory strategy based submissions factoring into various phases of development (IND phase 1-3) including the IND submissions, DSURs, Investigational brochures, Protocols, Protocol Amendments, ICFs, and expedited pathway submissions (Fast track, Breakthrough, Priority). KEY COMPETENCIES: ▸ eCTD Modules 1,2,3,4,5 Understanding ▸ ICH, CFR, GCP ▸ FDA Meeting Preparation / Execution ▸ Annual Reports (ODD/DSUR) ▸ Drafting IND, NDA, BLA Submissions ▸ Medical Writing ▸ Project Management ► REGULATORY BACKGROUND •Increased knowledge of regulatory requirements and strategies for documents needed for product approval and lifecycle maintenance (INDs, NDAs, BLAs, amendments, supplements, annual reports, and license renewals). •Enhanced understanding of the regulatory filing process including the eCTD module 1,2,3,4,5 structure systems. •Enhanced knowledge in both regulatory and compliance issues related to publications, clinical trials, and drug development. •Results driven regulatory professional with an experience in regulatory submission review, regulatory intelligence & strategy for development of FcRn targeted monoclonal antibody. •Goal oriented and innovative scientist having 5+ years of experience with an expertise in oncology drug discovery, and drug development, and nanoparticle formulation development. •Knowledgeable and understanding of clinical trials process including information about clinical endpoints, population enrolled, data collection, adverse event incident, and statistically relevant results report. ► HOW YOU CAN CONTACT ME [email protected]

• Which languages does Himgauri Naik speak? 

  Himgauri Naik speaks the following languages:
  No languages available.

• Which industries has Himgauri Naik previously worked in?   

  Himgauri Naik has prior experience in the following industries:
  Immunovant , Immunovant , Louisiana State University , University Of Louisiana At Monroe , University Of Louisiana At Monroe , Louisiana Tech University

• What is Himgauri Naik’s work experience?  

  Himgauri Naik has the following professional experience:
  Immunovant , Immunovant , Louisiana State University , University Of Louisiana At Monroe , University Of Louisiana At Monroe , Louisiana Tech University .

• How can I find Himgauri Naik on LinkedIn?  

  You can view Himgauri Naik’s
  LinkedIn profile at LinkedIn URL.

• What are Himgauri Naik’s work email addresses?  

  Himgauri Naik’s work email addresses are
  [email protected] .

• What company does Himgauri Naik work for?  

  Himgauri Naik works at
  Immunovant