Ira Kaduri
Plano, TX,TX
Summary
Regulatory Affairs Specialist with over 10 years of experience in pharmaceuticals, medical nutrition, and cosmetics. Expertise in global product registration, regulatory compliance, and cross-functional coordination with health authorities, distributors, and manufacturers. Strong knowledge of international regulatory requirements, including ingredients, labeling, product claims, and documentation processes.
Overview
12
12
years of professional experience
Work History
Regulatory affairs specialist
Abbott Medical Laboratories LTD
Tel Aviv
11.2016 - 11.2022
- Manage regulatory release of imported pediatric and medical nutrition products
- Coordinate documentation and data flow between supply chain, logistics, health authorities, and distributors
- Ensure compliance with Ministry of Health (MOH) requirements, including sampling and testing processes
- Review laboratory test results and verify compliance with product specifications and regulatory standards
Support product registration and license updates by reviewing submission documentation - Lead regulatory aspects of new product importation projects
Implement and define regulatory processes within internal systems (Regula)
Acted as interim Regulatory Manager and supported onboarding of new management - Developed and maintained regulatory documentation systems to support product approvals and audits.
- Collaborated with cross-functional teams to streamline product development processes and regulatory strategies.
- Reviewed labeling and promotional materials for compliance with regulations and company policies.
- Conducted training sessions on regulatory requirements for internal stakeholders, enhancing team knowledge and effectiveness.
- Monitored changes in regulations to advise on necessary adjustments to compliance strategies and practices.
- Coordinated responses to regulatory inquiries, ensuring timely communication and resolution of issues.
- Mentored junior staff on best practices in regulatory affairs, fostering professional growth within the team.
- Recommended improvements to processes.
- Conducted thorough audits to identify areas of improvement and implement corrective actions for regulatory compliance.
- Maintained detailed records of all regulatory activities, enabling quick access during inspections or audits.
- Facilitated productive communication between company management and regulatory agencies, fostering positive relationships.
- Participated in negotiations with regulators during inspections or audits, advocating on behalf of the company''s best interests while respecting agency expectations.
- Prepared and submitted regulatory file applications and supporting documentation.
- Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
- Provided training to colleagues on regulatory requirements, resulting in increased awareness and overall compliance within the organization.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
- Maintained and archived regulatory paperwork.
- Analyzed competitor data, staying informed about industry developments that could impact current or future products.
Regulatory affairs specialist
Pharma Cosmetics Laboratories LTD
Tel Aviv
11.2014 - 11.2016
- Registration of cosmeceutical products in Israel, Europe, China and Canada.
- Manage complaints folder.
- Manage the process of product development.
- Product manager of medical device registration.
- Managed registration and notification of cosmetic products in Israel, EU, China, and Canada
Ensured compliance with international cosmetic regulations (ingredients, labeling, claims, packaging)
Collaborated with distributors, consultants, and manufacturers to meet regulatory requirements and timelines
Supported product development and regulatory strategy for new product launches
Maintained product complaint files and supported post-market activities - Enhanced regulatory compliance by developing and implementing robust policies and procedures.
- Streamlined internal processes for timely submission of regulatory documentation to authorities.
- Reviewed advertising materials before release to verify claims were supported by scientific evidence, minimizing potential legal risks.
- Stayed updated on changing regulations by attending industry conferences, maintaining professional expertise in the field.
Research Laboratory Manager
Pharma Cosmetics Laboratories LTD
Tel Aviv
11.2010 - 11.2014
- Leading the process of developing new products prior their approval to production line.
- New products adjustment to the production floor, while conducting the required experiments.
- Manage Stability tests process of the company products.
- Worked closely with multiple interfaces: production, development team, marketing, sales and logistics.
- Trained and mentored junior staff on laboratory techniques, equipment usage, and best practices.
- Managed inventory of supplies and reagents, optimizing procurement processes to reduce costs.
- Collaborated with cross-functional teams to support product development initiatives and research projects.
Education
Master of Arts - Health Management
Ramat Gan Academic College
10-2014
Bachelor of Science – BS - Chemistry of Materials
Bar Ilan University
06-2008
Skills
- Global Regulatory Submissions & Product Registration
- Cosmetics Regulations (EU, Israel, International)
- Ingredient, Labeling & Claims Compliance
- Cross-functional Collaboration
- Regulatory Documentation & Dossier Preparation
- Post-marketing surveillance
- Regulatory submissions
- Labeling and packaging
- CAPA
- Project & Timeline Management
- Regulatory Intelligence & Monitoring
- Microsoft Office (Excel, Word, PowerPoint), Regulatory Systems management
Profile
- I.D: 306641960
- Phone number: 0526133477
- Email address: irakaduri@gmail.com
Languages
English
Native or Bilingual
Hebrew
Native or Bilingual
Russian
Professional Working
Timeline
Regulatory affairs specialist
Abbott Medical Laboratories LTD
11.2016 - 11.2022
Regulatory affairs specialist
Pharma Cosmetics Laboratories LTD
11.2014 - 11.2016
Research Laboratory Manager
Pharma Cosmetics Laboratories LTD
11.2010 - 11.2014
Master of Arts - Health Management
Ramat Gan Academic College
Bachelor of Science – BS - Chemistry of Materials
Bar Ilan University