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Shruti M. - 20954
6:51 PM, GMT +00:00
Shruti M. - 20954 Regulatory Affairs Specialist from Toronto
About
As a pharmacist, I am enthusiastic to apply for the position Regulatory Affairs Associate at your reputed organization. Back home, I hold a bachelor’s degree in Pharmaceutical Sciences and a knack in scientific publications and regulatory writing.
During my professional tenure in Drug Development, I have excelled in designing and optimizing the drug products, understood the regulations that bind to formulation concepts, aligned to the predefined timelines for project completion. I have been equipping myself by contributing articles relating to drug therapeutics in national and international journals. Being a workaholic, I have achieved a total of four international publications in the field of pharmaceutical sciences and novel treatments in renowned journals like Bioorganic Chemistry, Bentham Science and Cancer Cell targeting the current topics like diabetes mellitus, anticancer agents, and biomarkers that shows my writing skills and expertise in handling Microsoft tools (Word, Excel, and PowerPoint).
With my Masters in RA program, I have gained good theoretical knowledge on the regulatory submission process, regulatory compliance, and an understanding of eCTD (Electronic Common Technical Document) in the pharmaceutical industry. With the blend of formulation skills and regulatory knowledge, I am confident that I would be the best fit for the position. I would be more than happy if you could reach me over the phone or email me to schedule an interview. I look forward to hearing from you.
Thanks for your time and consideration.
Occupation
Regulatory Affairs Specialist
Work experience
2022 - Present
Pharmacy Assistant
Shoppers Drug Mart
2020 - 2021
Clinical Research Coordinator
CIDP, Rajendra Nagar
2019 - 2019
Regulatory Affairs Intern
1mg Technologies Pvt. Ltd
2018 - 2019
QC Analyst
Nestor Pharmaceuticals Ltd.
Education
2022 - Present
Northeastern University
Master of Science
2017 - 2021
School of Pharmaceutical Education and Research
Bachelor of Pharmacy
Skills
510(k)
3 Y
Biomarkers
3 Y
Biopharmaceuticals
3 Y
Biotechnology
3 Y
Clinical Research
3 Y
Diabetes
3 Y
Drug dispensing
3 Y
GLP
3 Y
Head Up Display
3 Y
Informed Consent
3 Y
LC-MS
3 Y
Pharmacology
3 Y
Quality Assurance
3 Y
Quality Control
3 Y
Regulatory Affairs
3 Y
Regulatory Documents
3 Y
Scientific Method > Hypothesis Testing
3 Y
Standard Operating Procedure
3 Y
Statistical Analysis
3 Y
Other skills
Biopharmaceutics
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