Syed Areef

### About Syed Areef H

 A dedicated and highly motivated professional in the field of Pharmaceutical Regulatory Affairs. I Completed my Master of Pharmacy (M. Pharmacy) at SRM College of Pharmacy in Kattankulathur, Chennai, where I have achieved an impressive CGPA of 9.29. Prior to this, I completed my Bachelor of Pharmacy (B. Pharmacy) from JSS College of Pharmacy in Ooty, graduating with a CGPA of 7.27. My educational journey has been marked by a strong academic performance and a deep commitment to the field of pharmacy.

Throughout my academic career, I have developed a robust set of technical skills that are crucial in the regulatory affairs domain. I possess comprehensive knowledge of International Council for Harmonisation (ICH) guidelines and have experience in preparing New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) dossiers for submission to markets in India, the US, and the EU. Additionally, I am proficient in the preparation of Common Technical Documents (CTD) tailored to country-specific regulatory requirements. This expertise is complemented by my understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), and current Good Manufacturing Practice (cGMP) standards.

My practical experience includes an internship at Strides Pharma Science Ltd in Bangalore, where I was involved in the preparation, review, and compilation of regulatory documents for annual reports submitted to the US market. This role also required me to manage documents in eCTD format using the Educe eCTD Dossier management tool and evaluate changes in the Trackwise and Online Artwork Management System tools. These responsibilities have provided me with hands-on experience in regulatory document management and compliance.

In addition to my technical skills and practical experience, I have undertaken significant academic projects that have further honed my expertise. For my M. Pharmacy project, I focused on "Project Management Strategies Involved in the Development of Generic Drugs and their Approval Process in the EU Market." During my B. Pharmacy, I worked on developing a herbal concoction against kidney stones using a novel combination of natural constituents. These projects have not only deepened my knowledge but also enhanced my research and project management skills.

Moreover, I have contributed to the field through various paper publications. My work includes reviews on regulatory science translational medicine, pharmaceutical quality management systems, pilot plant scale-up techniques, and the use of phytotherapy in managing kidney stones. These publications reflect my commitment to advancing public health and improving pharmaceutical practices through research and innovation.

I possess strong personal skills that complement my technical abilities. I am known for my hardworking nature, perseverance, and adaptability. I am a quick learner who thrives in professional and growth-oriented environments. My proficiency in MS Office and Adobe Acrobat further supports my capability to manage regulatory documents and projects efficiently.

Overall, I am a professional driven by a passion for pharmaceutical regulatory affairs, committed to enhancing my knowledge and skills continually. My academic achievements, technical expertise, practical experience, and personal attributes position me well to contribute significantly to any dynamic organization in the pharmaceutical industry.

During my internship at Strides Pharma Science Ltd in Bangalore, from September 2023 to February 2024, I gained hands-on experience in the field of pharmaceutical regulatory affairs. My responsibilities included the preparation, review, and compilation of regulatory documents for annual reports submitted to the US market. I worked extensively with the eCTD format, utilizing the Educe eCTD Dossier management tool to upload and formalize documents. Additionally, I evaluated changes proposed in the Trackwise and Online Artwork Management System tools. This role allowed me to develop a strong understanding of regulatory document management, electronic submission processes, and compliance with industry standards, providing me with valuable practical experience in the regulatory affairs domain.

I have completed my Master of Pharmacy (M. Pharmacy) in Pharmaceutical Regulatory Affairs at SRM College of Pharmacy, Kattankulathur, Chennai, with a commendable CGPA of 9.29, spanning from 2022 to 2024. 

 Bachelor of Pharmacy (B. Pharmacy) degree from JSS College of Pharmacy, Ooty, where I graduated in 2022 with a CGPA of 7.27.