GORBY SANDHU
Windsor,Ontario
Summary
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Overview
10
10
years of professional experience
Work History
Senior Regulatory Affairs Specialist
Dell Tech Laboratories Ltd.
06.2021 - Current
- Lead consultant in navigating Pest Control Products Act and Fertilizers act which includes responsibilities of making new product submissions and amendments to existing registrations for Pesticides to Pest Management Regulatory Agency (PMRA) and for Fertilizers to Canadian Food Inspection Agency (CFIA).
- Currently acting as regulatory contact for 40 plus companies with PMRA and CFIA which also makes me responsible to complete their annual mandatory reporting and defending them through re-evaluations, special reviews and audits.
- Assemble application packages for pesticide registration submissions to PMRA including application forms, confidential business information designation, English and French labels, product specification forms and data; chemistry, toxicology, metabolism, residue chemistry, environmental fate, environmental toxicology, value studies, summaries, risk assessments and interpretations, eIndexing the data into PRZ and submission to online gateway ePRS.
- Write Part 10 Value packages. Includes identifying pest issue, information on proposed product or solution, summary of efficacy trial report data and results, demonstration of benefits and contributions of proposed product or solution to resistance management.
- Assemble application packages for fertilizers submissions to CFIA including application form, marketplace label, product specification, results of analysis and safety rationale and supplemental data to online portal My CFIA.
REGULATORY AFFAIRS COORDINATOR
Jamieson Laboratories
03.2019 - 05.2021
- Coordinated the assembly of drug (DIN), natural health product (NHP) and cosmetic applications in a timely and accurate manner to Health Canada
- Reviewed preliminary formulations/concepts to help provide direction and strategy for new and existing products
- Helped identifying new product opportunities from a regulatory perspective
- Provided regulatory updates and impact to products and labeling to the business
- Created label texts and reviewed labels and promotional materials for compliance for all company divisionsbenefits for achieving compliance and competitive advantage
- Create label texts and reviewed labels and promotional materials for compliance for all company divisions
- Monitored and maintained site licence applications for all company divisions
- Trained regulatory associates for both domestic and international regulatory positions
- Stayed abreast of current regulations and communicate regulatory activity to ensure that the Company is aware of pertinent developments in labeling law, CHFA, Health Canada, FDA, USDA, etc.
INTERNATIONAL REGULATORY AFFAIRS ASSOCIATE
Jamieson Laboratories
06.2018 - 02.2019
- Provided regulatory support for multiple international markets (Australia, UK, Spain, France, China, Hong Kong, Taiwan, Indonesia, Malaysia, Romania, Slovakia, Slovenia, Trinidad & Tobago, Saudi Arabia, Palestine, Israel and UAE)
- Compiled product registration dossiers/CTDs and submitted in International Markets with local representatives and followed-up until obtaining local approvals and tracked submissions in the regulatory tracking database for all regions
- Ensured labels and artwork are in compliance with domestic and international regulatory requirements
- Was responsible for compiling required shipping documents like animal health certificates, fish health certificates, international trade certificates etc
- From regulatory bodies like CHFA, CFIA and CHP Canada
REGULATORY AFFAIRS ASSOCIATE
Medicap Laboratories
06.2017 - 05.2018
- Was solely responsible for providing the regulatory services to contract manufacturing customers
- Performed NHP formulas reviews, submitted NHP license applications, IRNs , NHP amendments and notifications within designated time frames
- Provided label compliance reviews , ingredient lists, supplemental facts, master files, export certificates from CHP and CHFA viz
- CFS, ITC-NHP, ITC-export only or other required regulatory documentation for clients of different markets like Canada, USA, Iran, India, Pakistan and Oman
CLINICAL RESEARCH ASSOCIATE
Ethicscare Clinical Research Services
07.2014 - 02.2016
- Completed tasks like taking informed consent forms from subjects, completing CRFs, patient follow-ups and query resolution
- Prepared Clinical study reports and made regulatory submissions involving study data
Education
Masters Of Clinical Research & Pharmacology -
Chitkara University
07.2015
Bachelors Of Pharmacy -
Chitkara College Of Pharmacy
07.2013
Skills
- Regulatory Strategy
- Pesticides Regulations
- Fertilizers Regulations
- Regulatory Affairs
- Regulatory Policies
- Data Verification
- Technical Documentation
- Regulatory Submissions
- Inspections
- Quality Assurance
- Labeling Compliance
Timeline
Senior Regulatory Affairs Specialist
Dell Tech Laboratories Ltd.
06.2021 - Current
REGULATORY AFFAIRS COORDINATOR
Jamieson Laboratories
03.2019 - 05.2021
INTERNATIONAL REGULATORY AFFAIRS ASSOCIATE
Jamieson Laboratories
06.2018 - 02.2019
REGULATORY AFFAIRS ASSOCIATE
Medicap Laboratories
06.2017 - 05.2018
CLINICAL RESEARCH ASSOCIATE
Ethicscare Clinical Research Services
07.2014 - 02.2016
Masters Of Clinical Research & Pharmacology -
Chitkara University
Bachelors Of Pharmacy -
Chitkara College Of Pharmacy
Similar Profiles
Joshua AgueneJoshua Aguene
Industrial Designer at Dell Tech CrewIndustrial Designer at Dell Tech Crew
SAI PRITHIVI RAYA KRISHNA BALUSUSAI PRITHIVI RAYA KRISHNA BALUSU
IT Service Desk Analyst at DELL Tech LtdIT Service Desk Analyst at DELL Tech Ltd
Ashish U HonnavarAshish U Honnavar
Advisor, Service Project/Program Manager at Dell International Services Ltd. / Dell TechnologiesAdvisor, Service Project/Program Manager at Dell International Services Ltd. / Dell Technologies