Profile
Nihilkumar Dhirubhai D. - 15680 Regulatory Affairs Associate from Canada
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Assigned
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Invites
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Payments
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Rate/hr
$19.41
User ID
Nihilkumar Dhirubhai D. - 15680
Toronto, Canada
6:34 PM, GMT -04:00

Nihilkumar Dhirubhai D. - 15680 Regulatory Affairs Associate from Toronto

About

Nihilkumar Dhirubhai Dobariya [email protected] | +1647-463-9855| https://www.linkedin.com/in/nihil-dobariya-0b50bab8/ To, The Recruiting Manager, Dear Manager, Hereby, I am writing to apply for the promising position that suits my profile. I believe my previous education coupled with my work experience in the clinical research and medical field makes me an ideal candidate for the mentioned role. Please accept my candidature with this application. I am a full-time student at Northeastern University, Toronto for MS in Regulatory affairs (CO- OP) for Drugs, Biologics and Medical devices and will be graduating on 2nd July-22. I have been studying since Sept21 and have successfully completed my all-academic semesters with overall GPA 3.5 and currently in capstone semester. At present I am legally allowed to work for parttime and continue further if given a chance once I complete my course by 1st week of July. So far, I have thoroughly learned about the detailed insights drug development various regulatory bodies their requirements, and application procedures for new pharmaceuticals and medical devices registration. Additionally, I am learning more about practical application of US FDA, EU, and MHRA guidelines, forms and timelines to be followed for each regulatory submission. My prior experience includes working in Drug development through global multicentric clinical trials (centralized monitoring) of Amgen at IQVIA (Formerly Quintiles, Research, India) on the diverse platforms of Electronic Data Capture (EDC) and paper-based trials with varied technological databases like Medidata Rave and Oracle clinical. I had successfully managed all the clinical studies right from protocol/database design, lab data reconciliation, data entry to interim analysis, and final lock with a team of 12 members. Lately, I had been working as a full-time pharmacist back home in India. I am particularly interested in Clinical research and technologies contributing to it and have had broad exposure right with my first job from my paid internship to working as a clinical data co-coordinator after my 2 promotions within 2years with an industry leader fortune 500 company, IQVIA (Formerly Quintiles Research PVT LTD, India). I am confident that my will definitely be an asset to the institution and I would be able to fulfill the job expectations to the best of my abilities. Especially, an initiative to incorporate the technology with a multidisciplinary approach for completing high-quality clinical studies that impacts broadly on people’s life, interests me more to work for such an organization. I have also been awarded often for my work at my earlier designation from punctuality to meet the deadline and quality of my work for the prompt site query resolutions. I am confident that my team leader experience, my skills, past/present education, and diverse pharmaceutical qualify me as a strong candidate for this opportunity at your esteemed organization. I believe that my education in pharmacology and the recent knowledge of regulatory affairs will be an advantage to work on projects for which fundamental pharmacology education is equally essential. As I currently residing in Toronto and I am eager to discuss my candidacy further with you and would welcome the opportunity to get myself interviewed in-person/virtual. Thank you for your time and consideration and I look forward to your response. Sincerely, Nihilkumar
Occupation

Regulatory Affairs Associate

Work experience
2020 - Present
International Student Counselor, Career Advisor
Advising international
2016 - 2021
Registered Pharmacist
Shree Ramdev Medical Store
2013 - 2016
Clinical Data Coordinator
IQVIA (Formerly Quintiles Research, India PVT LTD)
2013 - 2013
Data Management Intern
IQVIA (Formerly Quintiles Research, India PVT LTD)
Education
2020 - 2022
Northeastern University
Master of Science
2011 - 2014
Rajiv Gandhi University of Health Sciences
Master of Pharmacy- Pharmaceutical Sciences
2006 - 2008
The Oxford college of Pharmacy
Diploma
Calendar
June 2022
SU M TU W TH F SA
Available
Unavailable

Skills

Adobe Acrobat
9 Y
Clinical Trials
9 Y
Data Management
9 Y
Database Administration
9 Y
English
9 Y
GCP
9 Y
Indian > Gujarati
9 Y
Indian > Hindi
9 Y
Informed Consent
9 Y
Managerial Skills > Team Management
9 Y
Medical Records
9 Y
Microsoft Office
9 Y
Oncology
9 Y
Reconciliation
9 Y
User acceptance testing
9 Y

Other skills

Oracle Clinical
Osteoporosis
Psoriasis
Title 21 CFR Part 11

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