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@alinakhan1
Detail-oriented Drug Regulatory Affairs Executive with compliance expertise.
I am a detail-oriented Drug Regulatory Affairs Executive with over two years of experience in regulatory documentation, data analysis, and compliance. My expertise lies in case-handling processes and ensuring adherence to both global and local procedural documents. I have a strong ability to support performance-driven cultures and develop safety-related systems and processes, all while communicating effectively with stakeholders.
In my current role at Aravis Pharmaceutical, I have prepared over 100 regulatory documents, ensuring compliance with safety guidelines and patient safety objectives. My previous experience at Lucent Biotech Ltd. involved compiling and submitting numerous ACTD/CTD dossiers for various international markets, contributing to efficient product registration. I am passionate about leveraging my skills in pharmacovigilance operations to enhance patient safety and compliance.
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Work history, roles, and key accomplishments
Aravis Pharmaceutical
May 2024 - Present (1 year 6 months)
Detail-oriented Drug Regulatory Affairs Executive with experience in preparing regulatory documents, ensuring compliance with safety guidelines, and implementing safety-related processes. Proven track record in supporting patient safety objectives and improving regulatory workflows.
Lucent Biotech Ltd.
Feb 2023 - May 2024 (1 year 3 months)
Experienced Drug Regulatory Affairs Executive skilled in compiling and submitting regulatory dossiers for various markets. Analyzed regulatory queries and ensured compliance with technical documents, contributing to a high submission success rate.
Degrees, certifications, and relevant coursework
Bachelor of Pharmacy, Pharmaceutics
2018 - 2022
Grade: 8.14
Completed a Bachelor of Pharmacy with a major in Pharmaceutics, achieving a CGPA of 8.14. Developed a strong foundation in pharmaceutical sciences and regulatory affairs.
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