Bardia Varastehmoradi Email & Phone Number

Kastrup, Capital Region Of Denmark, Denmark

Capital Region, Denmark

As a Global Regulatory Affairs Professional at Novo Nordisk, I am responsible for developing and implementing regulatory strategies for submission packages based on ICH and health authorities' guidelines. My experience includes submissions to regulatory agencies such as EMA, FDA, Health Canada, PMDA, and Gulf countries, and supporting submissions.In my role, I collaborate with stakeholders around the world to ensure smooth communication and achieve common goals. This includes attending sprint meetings with product supply and medical writers to prepare and review quality documents in module 2 and 3 for submission packages. I am also experienced in assessing and handling regulatory needs for Changes and Deviations.My expertise extends to regulatory and quality management IT systems such as Change request assessment, Veeva systems, including Vault RIM.I am committed to staying up-to-date with changes in regulations and guidelines to ensure the success of my projects. I am excited to connect with like-minded professionals in the healthcare and pharmaceutical sectors, sharing knowledge and exploring the possibilities of making a positive impact together.

Århus Area, Denmark

As a Research Assistant/PhD Fellow, I was responsible for designing and executing experiments, including clinical and in vivo studies, animal modelling, biomarker studies, ELISA, and Western Blotting. I also analysed neuroimaging and microscopy images using IMARIS software and developed statistical design and analysis for experiments.In addition to my research responsibilities, I taught medical students and organized journal clubs. I conducted scientific writing in the field of neuropsychiatry and neuropharmacology and adhered to research integrity and ethical codes.My experience at Aarhus University and Aarhus University Hospital has equipped me with a strong foundation in research and a deep understanding of scientific writing and analysis.

Risskov, Central Region, Denmark

Århus Area, Denmark

Tehran

As a Pharmacist, Researcher, and Regulatory Affairs Assistant at NanoAlvand Pharmaceutical Co., I was responsible for developing anticancer medicines. In addition, I approved SOP and validation reports, prepared applications and CTD submissions, and conducted internal inspections of the production, audit, and QC departments.I was also responsible for counselling technicians in QC labs and product sites. Additionally, I conducted research to choose brand names for products.My experience at NanoAlvand Pharmaceutical Co. equipped me with a strong foundation in pharmaceutical research and regulatory affairs.

Tehran, Iran

I was responsible for managing the pharmacy, ordering medicines, and controlling buy/sell orders. I also checked prescriptions and medicines and formulated galenic medicinal products.In addition to my managerial responsibilities, I counselled patients, doctors, and other healthcare professionals. My experience at Rey Pharmacy equipped me with a deep understanding of the healthcare industry and the importance of providing exceptional patient care.

Tehran, Tehran Province, Iran

I was responsible for ensuring the quality of services provided by pharmacies, hospitals, and local pharmaceutical companies and wholesalers. I also advised doctors, KOLs, and HCPs and supervised pharmaceutical affairs.In addition, I conducted healthcare technician training and evaluated patient needs, ordering drugs and medicines for each county and village based on need estimation. My experience at the Health Network of the County equipped me with a deep understanding of the healthcare industry and the importance of ensuring that patients receive high-quality care.

Tehran - Iran

As an Expert and Medical Advisor at the Call Centre for DPIC (Drug and Poison Information Centre) at the Ministry of Health, I was responsible for counselling patients via hotline about disease and drug information. This included providing information on administration, interaction, side effects, pregnancy and lactation warnings, and other special conditions. I also provided information to HCPs and KOLs.In addition, I reported the probable adverse effect of medications to the supervisors and manager and referred the patient to healthcare centres. My experience at DPIC equipped me with a deep understanding of the importance of providing accurate and timely information to patients and healthcare professionals.

Doctor Of Pharmacy (Pharm.D.), Pharmaceutical Sciences

Activities and Societies: Seminars, Laboratories, Pharmaceutical Sciences As a pharmacy student at Tehran University of Medical Sciences.

Education record