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Roxana Huidici

@roxanahuidici

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Regulatory affairs pharmacist specializing in pharmaceutical and cosmetic product development.

Romania

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What I'm looking for

I seek regulatory or QA roles in pharma/cosmetics where I can lead submissions, ensure compliance with EU/ICH standards, mentor teams, and support product lifecycle development.

I am a pharmacist with specialized postgraduate training in pharmaceutical and cosmetic industry practices, currently completing a residency focused on product development, clinical research, quality control, regulatory affairs, pharmacovigilance, and quality assurance.

I have multi-year hands-on experience as a Regulatory Affairs Specialist supporting CMC strategies, lifecycle management, electronic submissions (DCP, RUP, national), and preparation of regulatory documentation including MAAs, variations, renewals, and ERA reports.

I collaborate across R&D, Quality, Production, Validation, and Medical Affairs to resolve regulatory challenges, align submission content and strategy, and mentor junior colleagues while managing a regulatory portfolio across multiple procedures.

My background includes pharmacy practice, quality control internships, and contributions to student professional organizations; I bring attention to regulatory detail, EU/ICH guideline familiarity, and practical patient-facing pharmacy experience.

Experience

Work history, roles, and key accomplishments

Current

Pharmacy Resident

Current

The Emergency University Hospital of Bucharest

Jan 2024 - Present (1 year 9 months)

Undertaking structured postgraduate training in pharmaceutical and cosmetic product development, clinical research, quality control, regulatory affairs, pharmacovigilance, and quality assurance; expected completion Jan 2027.

Regulatory Affairs Quality Control Clinical Research Pharmacovigilance Quality Assurance Product Development Documentation

Current

Regulatory Affairs Specialist

Current

S.C. Rompharm Company S.R.L

Jun 2020 - Present (5 years 4 months)

Supported development and implementation of regulatory CMC strategies for MAAs and lifecycle management, authored submissions and responses, managed a regulatory portfolio and executed electronic submissions for DCP, RUP, and national procedures.

Regulatory Strategy CMC RUP MAA ERA Reporting CTD

Regulatory Affairs Specialist

S.C. Hyperion S.A

Mar 2019 - Jun 2020 (1 year 3 months)

Provided regulatory support including compiling CTD Module 3 content for non-sterile semisolid generics, reviewing PILs/SmPCs and labelling for QRD compliance, and assisting daily regulatory operations.

CTD QRD Compliance Labelling ICH Guidelines Gap Analysis

Pharmacist

A&B Pharm

Oct 2018 - Mar 2019 (5 months)

Dispensed medicinal products per prescriptions and counselled patients on posology, drug interactions, side effects, and proper storage to ensure safe medication use.

Dispensing Prescription Drugs Patient Counselling Pharmacotherapy Record keeping Regulatory Compliance

Education

Degrees, certifications, and relevant coursework

Carol Davila University of Medicine and Pharmacy, Bucharest

Residency, Pharmaceutical and Cosmetic Industry Specialization

2024 -

Activities and societies: Structured postgraduate training at The Emergency University Hospital of Bucharest.

Residency in Pharmaceutical and Cosmetic Industry Specialization focusing on pharmaceutical and cosmetic product development, clinical research, quality control, regulatory affairs, pharmacovigilance, and quality assurance; expected completion January 2027.