Regulatory Affairs Specialist with 12+ Years Experience
Resume:
HANI ODETALLAH
Regulatory Affairs Specialist
CONTACT
PHONE:
EMAIL:
****.*************@******.***
Address:
Conway/AR
Willing to relocate.
EDUCATION
AL-Al Bayt University (Amman-Jordan)
2006 - 2010
B.S.C Degree of Chemistry
(Degree has been evaluated and accredited
for the USA through World Education
Services company (WES), confirming its
equivalency to a US bachelor’s degree).
(credential report enclosed)
LANGUAGES
- English
- Arabic
WORK AUTHORIZATION
USA permanent residence.
ABOUT ME
Experienced regulatory affairs with more than 12 years of experience in pharmaceutical industries ensuring compliance with global regulations. Strong background in preparing and submitting regulatory documents and CTD/eCTD dossiers to ensure compliance with FDA’s and EMA. Maintaining product registrations and managing relationships with health authorities. Focused on facilitating smooth product approvals and ensuring ongoing regulatory compliance throughout the product lifecycle. Seeking to contribute expertise in regulatory strategy and compliance to a forward-thinking pharmaceutical team. EXPERIENCE
-Fresenius Medical Care/PCT,
USA-LITTLE ROCK-AR
Setting Up and Operating Dialysis Machines, Monitoring Patients During Treatment, Patient Care and Communication, Maintenance of Equipment Ensuring Safety and Infection Control.
April/2024 – May/2025
- Sana Pharmaceutical Industry /Regulatory Affairs Head, Jordan-Amman
Develop Regulatory Strategy, Lead Regulatory Team, Oversee Submissions, Ensure Compliance, Risk Management, Stay Updated on Regulations, Educate and Train Staff.
Jan/2020 – May/2023
- Sana Pharmaceutical Industry /Validation and Compliance Supervisor,
Jordan-Amman
Ensure that all analytical methods are validated according to applicable regulatory guidelines, including FDA, EMA, ICH, and other global standards (e.g., ICH Q2, USP chapters, and GMP.
Sep/2019- Dec/2019
- Tabuk Pharmaceutical Manufacturing Co. /Senior Regulatory Affairs Officer,
Jordan-Amman
Preparing and submitting CTD, eCTD files, responsible for navigating complex regulatory requirements to secure product approvals and maintain compliance throughout the product lifecycle. lead regulatory strategy, manage submissions, ensure ongoing compliance, and collaborate with internal and external stakeholders also respond to regulatory inquiries. Jan/2017–Sep/2019
- Tabuk Pharmaceutical Manufacturing Co. /Research and Development Analyst,
Jordan-Amman
Perform stability studies on formulations to evaluate how drugs behave under different environmental conditions (temperature, humidity, light, etc.) and assess their shelf-life. Determine the physical, chemical, and pharmacokinetic properties of new drug candidates, including solubility, permeability, and chemical stability. Conduct various analytical tests on raw materials, intermediate products, and final formulations. This includes techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Vis Spectrophotometry, and Mass Spectrometry to determine purity, potency, and quality. June/2013–Dec/2016
- JOSWE Pharmaceutical Manufacturing Co. /Quality Control Analyst
Jordan-Na’our
Conducting various chemical and physical tests and analyses on raw materials, in-process materials, and finished products to verify their quality, safety, and compliance with regulatory standards. April/2011–May/2013
CERTIFICATES OBTAINED
Time management.
Self-Empowerment.
Bioequivalence, bioanalysis and biowaiver's concept and requirements as per JFDA, SFDA and EMA
Utilizing Emotional Intelligence for Management Effectiveness Guidelines Workshop.
The Puzzle of Motivation.
The power of Excel-Advance Skills.
English courses in British council center ‘Intermediate level' KEYS OF STRENGTH AND SKILLS:
Team leadership.
Well organized person.
Managing several data points and stakeholders.
The ability to work independently or as part of a team.
Ready to work at any time and to operate with more than the number of hours of action adopted.
Excellent communication, interpersonal and presentation skills.
The ability to work under pressure and perform well.
Advance Excel and Word Microsoft Skills.
Ready to give the best result in a short timeframe. PHARMACEUTICAL KNOWLEDGES
Preparation and Submission of medicinal products dossiers CTD, eCTD and validate it.
Preparation and Submission of Medical devices.
Preparation and Submission of Cosmetics.
Preparation and Submission of Products classification.
Expert on regulatory guidance.
Expert on registration regulation.
Expert on ICH guidelines.
Technical Documentation Skills.
Pharmaceutical development Skills.
Expert on Pharmacopeial monographs.
Expert on products Research and development.
Analytical Skills and problem solving.
Analytical Method Validation.
Laboratory Instruments expertise (HPLC-(Dionex, Thermo, Shimadzu), GC, TSP, Karl fisher, Dissolution).
REFERENCES
Available upon request.
Contact this candidate