Manjul Virmani

FAQ About Manjul Virmani

• What is Manjul Virmani's address?

  Manjul Virmani is located at
  Boston, Massachusetts, United States

• What is Manjul Virmani's job title?

  Manjul Virmani is a
  In search of a go-getter and highly motivated regulatory affairs professional? Look no further and keep reading. As an experienced professional, I hold an advanced degree in Regulatory Affairs from NEU coupled with a strong foundation in Pharmacy from my undergraduate studies. With zeal and a commitment to excellence, I have acquired valuable experiences in providing regulatory support to clinical programs through collaborating with cross-functional teams to coordinate and execute regulatory submissions to the health authorities, particularly in the rare disease landscape. I possess an inherent drive to be intellectually stimulated, leveraging my strategic mindset to delve into the intricacies of navigating complex regulatory frameworks and deciphering ever-changing regulations and guidelines across major and minor markets. I thrive in a supportive and infectious environment where I can apply my analytical thinking to interpret and translate regulatory requirements into actionable strategies that ensure compliance with the latest regulations and assist in approvals that will give patients access to safe and effective therapies. I am a constant learner and detail-oriented with a strong will to transcend to smart work by adapting to the dynamic environment of the regulatory affairs industry. The combination of rigorous academic coursework and professional experience has made me develop a strong understanding of US and global regulations to apply regulatory requirements to pre- and post-market products. With a well-rounded understanding of regulatory affairs, I maintain current knowledge of regulatory standards and industry trends for dossier preparation (IND/NDA/BLA/CTA/MAA). I am proficient in Veeva Vault RIM and the eCTD publishing tool (IQIVIA RIMSmart Pro) to support regulatory operations and publishing initiatives. I am well-versed in GxP standards, 21 CFR parts, and eCTD modules. Strong familiarity with orphan regulatory frameworks, ICH guidelines, CMC and quality guidelines, USFDA guidance documents, clinical trial monitoring & management, safety data collection & adverse event reporting, and Product labeling & advertising requirements. A resourceful individual who loves to stay current through reputable sources, such as Drugs@FDA, Drug bank, clinicaltrials.gov, USC, RAPS, and eCFR.gov. I would love to connect with like-minded regulatory professionals. Feel free to reach me at [email protected] AREAS OF INTEREST: Regulatory Strategy RA CMC Clinical trials monitoring & management Medical Devices submissions and documentation Healthy Design Exersides

• What industry does Manjul Virmani currently work in?

  Manjul Virmani currently works in the
  Healthy Design Exersides

• What is Manjul Virmani's area of expertise?

  Manjul Virmani specializes in
  In search of a go-getter and highly motivated regulatory affairs professional? Look no further and keep reading. As an experienced professional, I hold an advanced degree in Regulatory Affairs from NEU coupled with a strong foundation in Pharmacy from my undergraduate studies. With zeal and a commitment to excellence, I have acquired valuable experiences in providing regulatory support to clinical programs through collaborating with cross-functional teams to coordinate and execute regulatory submissions to the health authorities, particularly in the rare disease landscape. I possess an inherent drive to be intellectually stimulated, leveraging my strategic mindset to delve into the intricacies of navigating complex regulatory frameworks and deciphering ever-changing regulations and guidelines across major and minor markets. I thrive in a supportive and infectious environment where I can apply my analytical thinking to interpret and translate regulatory requirements into actionable strategies that ensure compliance with the latest regulations and assist in approvals that will give patients access to safe and effective therapies. I am a constant learner and detail-oriented with a strong will to transcend to smart work by adapting to the dynamic environment of the regulatory affairs industry. The combination of rigorous academic coursework and professional experience has made me develop a strong understanding of US and global regulations to apply regulatory requirements to pre- and post-market products. With a well-rounded understanding of regulatory affairs, I maintain current knowledge of regulatory standards and industry trends for dossier preparation (IND/NDA/BLA/CTA/MAA). I am proficient in Veeva Vault RIM and the eCTD publishing tool (IQIVIA RIMSmart Pro) to support regulatory operations and publishing initiatives. I am well-versed in GxP standards, 21 CFR parts, and eCTD modules. Strong familiarity with orphan regulatory frameworks, ICH guidelines, CMC and quality guidelines, USFDA guidance documents, clinical trial monitoring & management, safety data collection & adverse event reporting, and Product labeling & advertising requirements. A resourceful individual who loves to stay current through reputable sources, such as Drugs@FDA, Drug bank, clinicaltrials.gov, USC, RAPS, and eCFR.gov. I would love to connect with like-minded regulatory professionals. Feel free to reach me at [email protected] AREAS OF INTEREST: Regulatory Strategy RA CMC Clinical trials monitoring & management Medical Devices submissions and documentation

• Which languages does Manjul Virmani speak? 

  Manjul Virmani speaks the following languages:
  No languages available.

• Which industries has Manjul Virmani previously worked in?   

  Manjul Virmani has prior experience in the following industries:
  Healthy Design Exersides , Alexion Pharmaceuticals , Entero Healthcare , Order Genie Synergy , Max Healthcare , Sun Pharma

• What is Manjul Virmani’s work experience?  

  Manjul Virmani has the following professional experience:
  Healthy Design Exersides , Alexion Pharmaceuticals , Entero Healthcare , Order Genie Synergy , Max Healthcare , Sun Pharma .

• How can I find Manjul Virmani on LinkedIn?  

  You can view Manjul Virmani’s
  LinkedIn profile at LinkedIn URL.

• What are Manjul Virmani’s work email addresses?  

  Manjul Virmani’s work email addresses are
  [email protected].

• What company does Manjul Virmani work for?  

  Manjul Virmani works at
  Healthy Design Exersides