Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 50 /hr

★★★★★

☆☆☆☆☆

Hire Simona S.

Romania

USD 50 /hr

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

Profile Summary

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).

Subject Matter Expertise

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

Services

• Research
• Data & AI

Research Systematic Literature Review

Data & AI Statistical Analysis

Work Experience

RAQA Consultant

smarts regulatory consulting

March 2016 - Present

Education

Master Science

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

September 1992 - September 2001

Certifications

• QP Certification

  ANMDR

  September 2007 - Present