プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Simona S.に依頼

Romania

Regulatory Affairs & Quality Assurance with 15+ years of experience in pharmaceutical industry

プロフィール概要

Coordinated multiple number of regulatory and pharmacovigilance projects such as finalizing regulatory strategy roadmap, technical review of core documents, drafting of CTD dossier, eCTD compilation, query response drafting, variation package preparation and submission management to authority. Oversaw entire aspects regarding CSV validation project from concept to completion, started in 2018 at multinational firm (contractual basis).

専門分野

• ★ Regulatory Affairs
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Compliance

サービス

• Research
• Data & AI

Research Systematic Literature Review

Data & AI Statistical Analysis

職務経験

RAQA Consultant

smarts regulatory consulting

3月 2016 - 現在

学歴

Master Science

M.S. in Pharmaceutical University of Medicine and Pharmacy, Bucharest, Romania

9月 1992 - 9月 2001

認定資格

• QP Certification

  ANMDR

  9月 2007 - 現在