Sovan M.
Senior Manager @Amgen India
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WORK HISTORY
Senior Manager @Amgen India
Hyderabad, IN
Building and leading a high-performing global team Driving process excellence with a focus on achieving 95% “Right First Time” metrics Implementing innovative automation tools and continuous improvement methodologies Collaborating cross-functionally with Regulatory Affairs, Artwork, and other partners Acting as a strategic advisor on end-to-end labeling processes Spearheading global projects across therapeutic areas with a focus on scalability and quality
EDUCATION
Medical Campus, Govt. High School
Matriculation
Royal College of Pharmacy & Health Sciences: Bijju Pattnaik University of Technology
Bachelor, Pharmacy
Binayak Acharya Junior Science College
Intermediate, Science (Biology)
PRIST University - India
Master of Science - MS, Clinical Research
ICRI India
PGD, Pharma Business Managment
ABOUT SOVAN M.
With over 16 years of experience in pharmaceutical regulatory services, healthcare IT, Project Management, and cross-functional leadership, I have led large-scale regulatory projects, delivering high-quality results ensuring compliance and operational excellence. I specialise in managing global labeling (cCDS, SmPC, USPI), medical writing (clinical and scientific), systematic literature reviews, and regulatory intelligence, driving process optimisations, and implementing tech-enabled solutions (SDLC) to enhance efficiency and quality compliance.I have a proven track record of leading cross-functional teams (direct and indirect reports) across various regulatory domains and projects. As a seasoned leader, I have driven strategic regulatory initiatives, managed multi-million-dollar projects, and fostered high-performing teams by integrating data-driven decision-making and risk mitigation strategies.I bring expertise in project lifecycle management, resource planning, and stakeholder engagement, ensuring successful regulatory submissions and compliance with global health authorities (FDA, EMA, HC, MHRA, and DCGI). With a strong focus on team mentorship, performance optimisation, and workflow automation, I am committed to delivering innovative and compliant regulatory solutions.
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