Summary
Overview
Work History
Education
Skills
Timeline
Generic

Samaher Alfaifi

Senior Regulatory Affairs Specialist
Riyadh

Summary

Accomplished Senior Regulatory Affairs Specialist with a proven track record at Mesned Pharma Consult Center, adept in SFDA systems and expert in regulatory compliance. Demonstrated success in reducing submission times by 25% and leading over 1000 product approvals. Renowned for exceptional negotiation skills and technical documentation prowess, ensuring client satisfaction and product compliance.

Overview

7
7
years of professional experience

Work History

Senior Regulatory Affairs Specialist

Mesned Pharma Consult Center
05.2019 - Current
  • Spearheaded the preparation and submission of technical documentation, ensuring precise and timely licensing materials for food and food supplement products in strict alignment with Saudi regulations and GSO Guidelines.
  • Assessed product compliance with both local and international regulations to guarantee adherence to stringent safety standards.
  • Advised importers and distributors on regulatory policies, ensuring full comprehension and adherence to applicable laws and regulations.
  • Provided expert counsel on regulatory matters, including product registration, documentation, and compliance strategies, to support clients in navigating complex requirements.
  • Reviewed technical data and reports to ensure regulatory accuracy, performing thorough assessments before submission.
  • Crafted and edited product labels for clarity, accuracy, and compliance, making them both user-friendly and regulation-compliant.
  • Negotiated with regulatory authorities to expedite product approvals, addressing and resolving regulatory challenges efficiently.
  • Led the regulatory registration process for over 1000 food and food supplement products with the Saudi Food and Drug Authority (SFDA), ensuring full regulatory compliance and securing 100% approval within set timelines.
  • Developed and implemented a streamlined product labeling review system, ensuring 100% compliance with SFDA guidelines and effectively preventing regulatory penalties.
  • Directed regulatory inspections and audits for food supplement products, ensuring full compliance with SFDA and GSO standards, culminating in a flawless audit with zero non-compliance issues.

Translator and Interpreter

Juan Rehabilitation Center
01.2018 - 04.2018
  • Translated written texts between Arabic and English, ensuring accurate and culturally appropriate communication for diverse audiences.
  • Managed office tasks and handled paperwork, maintaining efficient organization and supporting daily administrative operations.
  • Proofread and edited translated materials, ensuring clarity, accuracy, and consistency in both Arabic and English texts. Collaborated with team members to deliver high-quality translations within tight deadlines, ensuring all documents met required standards.

Education

Bachelor of Arts - English Language And Translation

King Saud University

Skills

Proficient in SFDA systems; GHAD, FASAH and SABER Advanced Microsoft Office (Excel, PowerPoint)

Excellent communication and negotiation skills with regulatory agencies

Risk management and problem-solving abilities

Strong technical writing and documentation skills

Timeline

Senior Regulatory Affairs Specialist

Mesned Pharma Consult Center
05.2019 - Current

Translator and Interpreter

Juan Rehabilitation Center
01.2018 - 04.2018

Bachelor of Arts - English Language And Translation

King Saud University

Similar Profiles

CREATE PROFILE
Samaher AlfaifiSenior Regulatory Affairs Specialist