DHRUVAL CHAUDHARY
Longmont,CO
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
Hospitality Management
MGB Investment LLC
05.2022 - 10.2023
- Recruit, train and manage employees to deliver quality guest services that will lead to maximizing revenue
- Renegotiated several contracts in order to increase revenue
- Ensure the hotel is in compliance with federal, state and local laws
- Protect the hotels financial assets by properly administering policies and procedures for handling cash, credit cards, accounts payable, accounts receivable, payroll and all other financial transactions
- Responsible for the preparation of the property budgets and ensuring purchases are within the budget.
Regulatory Specialist - US Compliance
Ferrara Candy Company
01.2021 - 10.2021
- Provided food and nutrition, labeling, and regulatory expertise such that business goals of the divisions were supported and advanced to ensure regulatory compliance and responsible marketing and sales actions
- Maintained Genesis records to support FDA label compliance
- Reviewed and substantiated claims and provided regulatory guidance on claims to the organization
- Provided technical guidance as appropriate in response to product related consumer inquiries
- Review and approve regulatory electronic Raw Material Dossier for new and existing raw materials
- Ensured the accuracy of the regulatory information on final label artwork in conjunction with cross-functional teams
- Reviewed, registered and certified raw materials and finished goods with Kosher, Organic, Non-GMO certifying bodies.
International Regulatory Compliance Specialist
Ferrara Candy Company
08.2019 - 01.2021
- Collaborated with Marketing, Sales, Product development, Quality and Legal department to understand business needs and fulfill international regulatory requirements
- Worked as a liaison between consultants, distributors and foreign liaisons to ensure products, formulation and labels are in compliance with regulations of international markets
- Assisted in submitting documents for facility registration in Canada and Mexico
- Prepared, requested and assembled export documents such as Certificate of Free Sale, USDA Health Certificate, Product Specifications, Certificate of Origin
- Assisted distributors in requesting export documentation and provided certificates of quality and audit for product registration in international markets.
R&D Sr Specialist Regulatory Affairs
PepsiCo Global R&D
11.2016 - 08.2019
- Ensured compliance of formulas and labelling according to the Nutritional Label Reform
- Developed and ensured compliance of nutritional facts, ingredient statements, allergen declaration and claims with regulations
- Assessed in depth regulatory compliance for Import/Export requests or products
- Answered consumer inquiries regarding ingredients, compliance with kosher and halal requirements, or possible allergies
- Reviewed and approved regulatory electronic Raw Material Dossier for innovation and legacy ingredients
- Ensured the accuracy of the regulatory information on final artwork
- Managed kosher certification of products
- Performed software update and testing for better user experience.
Research Participant Recruitment Supervisor
Fieldwork Market Research
02.2019 - 05.2019
- Allocate projects and interact with project team members to ensure timely and efficient execution of studies
- Brief project teams on timeliness, responsibilities and study specifications
- Provide project management support to ensure participants recruited meet studies objectives
- Plan the execution of project in terms of cost, time, resources and quality of recruitment process
- Communicate study progress and discuss issues with project managers.
Research Intern
WntRx Pharmaceuticals
02.2016 - 06.2016
- Worked on strategic planning, budget plan and commercialization plan for NIH grant applications
- Prepared grant proposals for government funding opportunities which included specific aims of the testing, budget justification and collecting support letters from Contract Research Organizations (CROs)
- Selected CROs and vendors for testing and chemicals.
Market Research Interviewer
Sigma Research and Consulting Pvt. Ltd
03.2014 - 05.2014
- Compared the effectiveness of Intrauterine devices used in local hospitals
- Conducted face-to-face interviews with people on knowledge, attitude, behavior and practices on HIV and AIDS
- Conducted survey on impact of Mid-Day Meal program in government schools on attendance, performance, and health of underprivileged children.
Education
Master of Science - Regulatory Affairs for Drugs, Biologics and Medical devices
Northeastern University
Boston, MA07.2016
Bachelor of Pharmacy -
Gujarat Technological University
06.2014
Skills
- Documentation Management
- Technical communication
- Expert Problem Solving
- Labeling Compliance
- Pharmaceutical Regulations
- Medical Device Regulations
- Documentation Review
- Product Registration
- Regulatory Submissions
- Global Regulatory Compliance
- Regulatory Policies
- Regulatory Agency Applications
Timeline
Hospitality Management
MGB Investment LLC
05.2022 - 10.2023
Regulatory Specialist - US Compliance
Ferrara Candy Company
01.2021 - 10.2021
International Regulatory Compliance Specialist
Ferrara Candy Company
08.2019 - 01.2021
Research Participant Recruitment Supervisor
Fieldwork Market Research
02.2019 - 05.2019
R&D Sr Specialist Regulatory Affairs
PepsiCo Global R&D
11.2016 - 08.2019
Research Intern
WntRx Pharmaceuticals
02.2016 - 06.2016
Market Research Interviewer
Sigma Research and Consulting Pvt. Ltd
03.2014 - 05.2014
Master of Science - Regulatory Affairs for Drugs, Biologics and Medical devices
Northeastern University
Bachelor of Pharmacy -
Gujarat Technological University