11/16/2024 updated
100 % available
Experienced Global Regulatory Affairs Specialist
Utrecht, Netherlands
Only remote
Pharm D., University of Toronto (comparative education services)Data AnalysisComplianceConsultingElectronic Common Technical DocumentElectronicsFood ChemistryFood SafetyFood QualityProject ManagementMedicinePharmaceuticalsPharmaceutical SciencesMicrosoft SharePointStakeholder ManagementPharmaceutical Regulations
Regulatory Affairs Expertise
Extensive experience in global regulatory affairs, specializing in pharmaceutical and food industries across multiple time zones.
Project Management
Skilled in managing remote regulatory projects, leveraging tools like Microsoft Teams, Zoom, and SharePoint for effective collaboration.
Compliance Management
Proficient in ensuring timely compliance with international regulatory agencies and managing the life-cycle of medicine dossiers.
Regulatory Submissions
Expertise in preparing and managing electronic regulatory submissions via eCTD system for EU/EEA and global medicine dossier submissions.
CMC Data Analysis
Proficiency in CMC data analysis and writing regulatory dossiers (Module 3) for pharmaceutical products.
Food, Beverage, Food Supplement, Food Ingredients
Proficiency in formulation analysis to be inline with regulatory framework for Food, Beverage, Food Supplement, Food Ingredients.
Stakeholder Management
Skilled in advising senior management and business unit heads on regulatory landscape and future developments.
Extensive experience in global regulatory affairs, specializing in pharmaceutical and food industries across multiple time zones.
Project Management
Skilled in managing remote regulatory projects, leveraging tools like Microsoft Teams, Zoom, and SharePoint for effective collaboration.
Compliance Management
Proficient in ensuring timely compliance with international regulatory agencies and managing the life-cycle of medicine dossiers.
Regulatory Submissions
Expertise in preparing and managing electronic regulatory submissions via eCTD system for EU/EEA and global medicine dossier submissions.
CMC Data Analysis
Proficiency in CMC data analysis and writing regulatory dossiers (Module 3) for pharmaceutical products.
Food, Beverage, Food Supplement, Food Ingredients
Proficiency in formulation analysis to be inline with regulatory framework for Food, Beverage, Food Supplement, Food Ingredients.
Stakeholder Management
Skilled in advising senior management and business unit heads on regulatory landscape and future developments.
Experience
Professional experience10+ years
Freelancer since2022
Languages
EnglishFluentDutchFluent
Project history
Responsible for timely registration of medicines at national and European level, CMC data analysis, supervising submissions to government, and ensuring regulatory compliance.
Led remote consultations with stakeholders across Europe and APAC regions, provided regulatory guidance, and managed food legislation knowledge for business units.
Guided stakeholders on product safety and legislative expertise, monitored food regulatory developments, and ensured compliance with laws and regulations.