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Mariacristina Nicolosi

@mariacristinanicolos

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Pharmacist at Vaccarello Pharmacy after managing global drug and medical-device regulatory submissions at Baxter.

Italy

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What I'm looking for

My goal is to excel in a role of significant responsibility, where I can contribute value to stakeholders while achieving personal and professional growth.

At Vaccarello Pharmacy, I dispense prescription and over-the-counter medications and advise patients on their use, dosage, side effects, and interactions. I also manage medication inventory and support patients with pharmaceutical care.

At Baxter, I managed US and EU regulatory submissions for drugs and medical devices, including NDA, ANDA, MAA, lifecycle variations, and 510(k) submissions. I also managed regulatory renewals across LATAM, the Middle East, South Africa, and Australia, and tracked project timelines and submission requirements.

At Aurobindo, I reviewed laboratory documentation and raw data for compliance, prepared Certificates of Analysis, and handled analytical testing using methods including HPLC, UV, and MS-UPLC. I hold a Pharmacist Warrant and RAC Drugs certification, and my thesis was recognized with the Federfarma Prize 2024.

Experience

Work history, roles, and key accomplishments

Current

Pharmacist

Current

Vaccarello Pharmacy

Mar 2025 - Present (1 year 7 months)

Dispense prescription and over-the-counter medications, ensuring accuracy and compliance with regulations. Provide patient advice on medication use and manage inventory.

Pharmacy Medication dispensing Regulatory Compliance Inventory Management Patient Counseling

Sr Global Regulatory Affair Specialist

Baxter

Jan 2022 - Feb 2025 (3 years 1 month)

Managed end-to-end US and EU regulatory submissions for drugs and medical devices, including NDAs, ANDAs, MAAs, and lifecycle variations. Coordinated cross-functional teams and managed regulatory projects.

Regulatory Affairs FDA Regulations EU Regulations CMC Trackwise RIMVault Project Management Cross functional Coordination

QC Reviewer

Aurobindo

Mar 2021 - Dec 2021 (9 months)

Coordinated review of laboratory documentation and provided compliance support for batch release. Reviewed raw data ensuring GMP and GDP, and prepared Certificates of Analysis.

Quality Control GMP GDP Empower System LIMS Batch Tracker Documentation Review

QC Analyst

Aurobindo

Nov 2019 - Feb 2021 (1 year 3 months)

Performed analytical testing including assay, dissolution, and related substances using HPLC, UV, and MS-UPLC. Conducted physical tests and ensured compliance with SOPs and GMP.

HPLC UV развертка UPLC Karl Fischer Titration Dissolution Testing GMP SOP Compliance

Education

Degrees, certifications, and relevant coursework

RAC

RAC Drugs Certification, Regulatory Affairs

RAC Drugs Certification, certified badge.

Università degli Studi di Catania

Pharmacist Warrant, Pharmacy

Licence to practice as a pharmacist in Italy and in any EU country.

Università degli Studi di Catania

Master's degree, Medicinal Chemistry and Pharmaceutical Technology

2014 - 2019

Grade: 110/110 with honours

Activities and societies: Student representative, academic year 2017/2018

Master's degree in Medicinal Chemistry and Pharmaceutical Technology. Thesis on synthesis and biological evaluation of novel β-cyclodextrin-fluvastatin conjugates, final grade 110/110 with honours.