Profile

Shivali Desai

Contact Details

Canada
RegEx Rising Star
RegEx Pro

Bio

• Bachelor in Pharmaceutical Science, post graduate certificate in regulatory affairs from AAPS,Canada • Perusing RAPS certification course of Pharmaceuticals: Canadian regulations • CAPRA (Canadian Association of Professionals in Regulatory Affairs) membership • RAPS membership • Currently working in Amazon, Canada • 8 months of Canadian regulatory affairs experience as work from home type work for export of Active pharmaceutical ingredients, biochemical, small molecules from India to Canada • 5+ years of experience in regulatory submissions of pharmaceutical finished products and medical device in US,EU,Austrelia,Health Canada, African, S.E.Asia,Latin America • 7 months of experience as volunteer at Pharmacy in Mississauga as Pharmacy Assistant • Basic knowledge and understanding on current Canadian GMP guidelines, NDS,SNDS,CTA submissions and U.S. regulations for ANDA • Ability to interpret and apply ISO, ICH guidelines and regulatory guidelines/regulations • Ability to work in fast pace environment with minimum supervision to meet deadlines • Well managed ,self-motivated with effective organizational skill • Time management, leadership and effective communication skills ,proven problem solving ability to make decisions at workplace • Computer skills: Microsoft Office and basic knowledge of ERP software, e-CTD complaint software ,Fill ware software

Education

L.M.College of Pharmacy
Ahmedabad, India
Bachelor in Pharmacy, 2002
Pharmacy

Year Entered Profession

  • 2005-2009

Current Organization Type

  • Industry Organization

Job History

FC Associate
Mississauga, ON, Canada
August 2019 - present

Sr.Regulatory Affairs Associate
Ahmedabad, India
April 2018 - May 2019

Regulatory Affairs Associate
AHMEDABAD, India
June 2014 - July 2017

Regulatory affairs associate
AHMEDABAD, India
August 2008 - January 2014

Highest Degree Earned

  • Associate

Regional Interests

  • North America

Product Interests

  • API's
  • Cosmetics
  • Foods
  • Generic Drugs
  • Innovative Pharmaceuticals
  • Medical Devices
  • Nutritional/Natural Health
  • OTC drugs