GCC REGULATORY AFFAIRS
PHARMA SUMMIT 2025

Dr. Lamis Youssef is the Senior Regulatory Affairs Manager, Gulf cluster in Pfizer. She has over 12 years of experience in Regulatory Affairs (RA) across the pharmaceutical industry.

She joined Pfizer in 2016 as Regulatory affairs manager handling Africa middle east region for a diverse portfolio & was responsible for the Regulatory management of Hospira acquisition within Africa middle east region. In her current role, Dr. Lamis is handling multiple therapeutics areas for innovative portfolio.

She is also an active member within the Gulf trade association and is currently leading the Trak & Trace and e-labelling taskforce within Regulatory Affairs working group.

Before joining Pfizer, Lamis worked as regulatory affairs for J&J medical devices and  Julphar, prior joining regulatory she had different roles working as production and quality assurance expert in different pharmaceutical companies in Egypt including Sigmatec and GSK.

Dr. Lamis graduated from faculty of Pharmacy 6^th October university, she has a six sigma green belt certificate and she is currently pursuing her MBA.

Dr. Yousra is a Regulatory Affairs and Commercial & Distribution Quality Assurance Director, Strategic Project Lead with over 18 years of diversified experience from various leadership positions in Regulatory Affairs , Quality Assurance within Health Authority as well as multinational organizations at both regional and local levels.

Dr. Yousra is currently leading Abbott-Gulf, Levant & Emerging Markets Regulatory Affairs, Quality Assurance and Strategic Projects. In her role in Abbott Established Pharmaceutical Division; Yousra is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing & Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as Regulatory risk mitigation and regulatory compliance.

Dr. Yousra has set effective regulatory strategies of external engagement including Health authorities, local distributors, trade associations and Third-Party Manufacturers. This is in addition to her Quality Assurance responsibilities of establishing and embedding Quality Management System within GEM & Levant.

On top of that, she set the base for strategic projects within the Gulf & Emerging Markets and lead the execution of a variety of initiatives that support patient centricity.
Dr. Yousra is holding a bachelor of pharmaceutical sciences from Cairo University and RAPS-DPC certification/USA-UAE and She has also completed the “New Leadership Program (NLP)”, by Harvard Business School and is currently enrolled in “Professional Diploma in Business Planning and Strategy”, by Rochester Institute of Technology, USA.

She is a prime pharmacist, and the head of 1st registration committee in registration department/directorate technical affairs/ Iraqi MOH. She recently became the manager of pharmacy department in the same directorate-MOH.

A collaborative, strategic professional with a highly result oriented and problem-solving mind.  Almost 17 years of regulatory affairs practice and efficient training courses gave him a solid and enriched knowledge in different regulatory aspects in terms of registration of medicinal products; GSL products and medical devices, Marketing authorization functions, post approval changes and renewal process. His core strengths and competencies are building new Regulatory departments and leading cross functional team as well as developing creative regulatory solutions that reflect on achieving the company organizational commercial targets and business objectives successfully.

Dr. Rawya is a clinical pharmacist with broad Medical and Pharmaceutical knowledge, experience in various aspects of the Pharmaceutical Industry especially Medical Affairs, Regulatory Affairs and Pharmacovigilance, as well as knowledge and experience in the research field. She has a M.Sc. Clinical Pharmacy (with Distinction) – Queen’s University, UK.

Dr. Rawya began her career at Hikma Pharmaceuticals, Jordan since 1998 till 1999, and she is currently the Regulatory Affairs & Medical Affairs Director at Gulf Pharmaceutical Industries (Julphar), Ras Al Khaimah, United Arab Emirates since 2020 – to the present date.

In her role in Regulatory affairs, she displays and actions leadership in all aspects of Regulatory Affairs for company product portfolio of generics and novel products, including product development and submissions.

She is also an expert in defining the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget. In addition, Dr. Rawya is knowledgeable of partnering with R&D and Global Strategic Marketing leaders as well another functional leader to develop and implement strategy for pipeline development and global launch excellence.

Dr. Rana holds a master’s degree in pharmaceutical quality assurance, with more than 16 years of experience in the field of Regulatory affairs, both the theoretical knowledge on legislations governing medical products & the understanding of the technicalities involved in regulatory submission.

Also serving as head of the clinical studies department for more than 5 years gave her experience in the field of clinical trials operations & GCP guidelines.

Also she was a member of the regulatory team who collaborated in the preparation & review of the “Guidance for Registration of Biosimilars in Jordan” that was published in May/2015, also she is a well-recognized speaker in the field of Biosimilar regulations & requirements, also she has fair knowledge in Intellectual property & public health issues related to pharmaceuticals.

She started her career in the private sector then moved to JFDA in 2008, since then she has held many positions including head of new drugs registration section, head of biological and vaccine registration section, head of Clinical Studies Department, administrative assistant to director general.

She chaired and was a member of many technical committees at JFDA and MOH.