Open to opportunities

Melisa Mandrutiu

@melisamandrutiu

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Detail-oriented Regulatory Affairs & Pharmacovigilance Associate.

Romania

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What I'm looking for

I am looking for opportunities in regulatory affairs and pharmacovigilance that foster growth and collaboration.

I am a detail-oriented Regulatory Affairs & Pharmacovigilance Associate with a strong pharmacy background and over three years of experience in pharmaceutical compliance and drug safety. My expertise lies in regulatory documentation, submission processes, and ensuring adherence to Good Regulatory Practices (GRP) and European Medicines Agency (EMA) guidelines.

In my current role as a Community Pharmacist, I ensure compliance with pharmaceutical regulations and conduct thorough regulatory documentation reviews. I am passionate about drug safety monitoring and lifecycle management, and I thrive in collaborative environments where I can contribute to regulatory guidance and risk management.

Experience

Work history, roles, and key accomplishments

Current

Community Pharmacist

Current

SC DUCFARM SRL

Oct 2021 - Present (3 years 7 months)

Detail-oriented Community Pharmacist with a focus on regulatory affairs and pharmacovigilance. Responsible for ensuring compliance with pharmaceutical regulations, conducting documentation reviews, and assisting in drug safety monitoring. Skilled in managing electronic medical records and providing regulatory guidance on various pharmaceutical products.

Regulatory Compliance

Education

Degrees, certifications, and relevant coursework

Iuliu Hațieganu University of Medicine and Pharmacy

Bachelor and Master Degree in Pharmacy, Pharmacy

2016 - 2021

Grade: 8.64

Activities and societies: Research focus on drug safety, pharmacokinetics, regulatory intelligence, signal detection, and clinical trial regulations.

Completed a Bachelor and Master degree in Pharmacy with coursework in Regulatory Affairs, Pharmacovigilance, Drug Development, Clinical Trials, and Medical Writing. Developed a strong foundation in pharmaceutical law, quality assurance, risk management, and regulatory submissions.