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
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