Syed Aqueeluddin Ahmed
Deputy General Manager @Viatris
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WORK HISTORY
Deputy General Manager @Viatris
IN
Successfully led the management submission and responses of deficiencies of the Rest of the World Submission expertly overseeing all (OSD) Oral Solid products.• Strategically Planned, Executed, and Maintained registration Dossiers for various emerging markets including re-registration and Company Registration ensuring thorough compliance and efficiency. • Guaranteed the seamless generation of a Certificate of Pharmaceutical Products, & Manufacturing license strictly adhering to the country-specific regulations and exceeding customer requirements.• Coordinated effectively with International Marketing, R&D, Quality Assurance, Production, Contract Manufacturing Sites, Supply Chain, and Medical Division to deliver Mylan’s projects on time and to high standards. • Conducted comprehensive regulatory compliance audits through on-site visits ensuring all filing requirements were not just met but exceeded.• Reviewed and Approved Chemistry, manufacturing, and Control (CMC) documents for regulatory submissions with precision, showcasing diligence and expertise. • Performed critical assessment of Data from Formulation & Development, Analytical Development Laboratory, Quality Assurance, Manufacturing site, and Quality Control Department ensuring data integrity and compliance.• Ensured the prompt and effective submission of technical data in response to queries received from Regulatory Authorities for products under-registration demonstrating a proactive approach to compliance.
EDUCATION
Maharashtra College of Pharmacy, Nilanga, Dist.Latur
B.Pharmacy, Pharmacy
Y.B. Chavan College of Pharmacy Aurangabad
M.Pharmacy, Quality Assurance
SKILLS
ABOUT SYED AQUEELUDDIN AHMED
I am a highly accomplished Regulatory Affairs Professional with over 25 years of extensive experience leading submissions and deficiency responses in diverse Rest of the World (ROW) markets. My expertise spans a wide array of oral Sold dosage, Liquid Oral, and Injectable products, and I excel in strategically planning, executing, and maintaining precise registration dossiers for emerging markets, including both re-registration and company registration.With a strong proficiency in getting Certificates of Pharmaceuticals Products (COPPs) and manufacturing licenses, I ensure uncompromising compliance with country-specific regulations and customer expectations. I effectively drive collaboration across cross-functional teams comprising international markets, R&D Quality Assurance Production, contract manufacturing sites, supply chain, and the medical division ensuring timely project delivery without compromise. My skill set includes conducting thorough regulatory compliance audits reviewing and approving Chemistry. Manufacturing and Control (CMC) documents and performs critical assessments of the data from various departments, consistently meeting regulatory submission standards. I have a proven track record of managing successful submissions and deficiency responses across multiple regions including CIS, Asia Africa, Central and South America, and the Middle East. My in-depth expertise encompasses various finished dosage forms, such as tablets capsules injection suspension ointments, and syrups backed by strong technical knowledge in CTD format submissions for countries including New Zealand, Malaysia, Jordan, Iran, Saudi Arabia, Turkey Serbia, and Israel.Renowned for my exceptional leadership, project management, planning, and organizational skills. I am a compelling communicator with a keen eye for details. I am dedicated to delivering high-quality results efficiently and operate as a committed team player, driven by the goal of achieving regulatory compliance and surpassing business objectives.
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