Zaiton S
Regulatory Start Up Manager at Novotech | Malaysia
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Zaiton S. currently serves as a Regulatory Start Up Manager at Novotech, where she plays a pivotal role in streamlining the complex processes involved in clinical trial site activation across multiple regions, including APAC, EU, the UK, and the US. Her leadership is instrumental in coordinating cross-functional teams to ensure timely regulatory submissions, site initiation, and readiness for patient recruitment. With over five years of extensive experience in regulatory affairs and start-up management, Zaiton has developed a deep expertise in navigating diverse regional regulatory landscapes, including the intricacies of the CTIS application process for EU sites. Her proficiency in managing regulatory submissions, ensuring compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), and utilizing advanced tools like Veeva Vault has significantly contributed to the successful initiation of numerous clinical trials.
Zaiton’s strategic approach to project planning and functional management ensures that all stakeholders—from site staff to regulatory authorities—are aligned and informed throughout the trial lifecycle. Her expertise extends to site start-up activities, from site qualification and regulatory document collection to site activation and ongoing compliance monitoring. She is also adept at translating complex regulatory requirements into actionable tasks, facilitating smooth communication across international teams. Her leadership in managing CTIS applications exemplifies her ability to adapt to evolving regulatory frameworks, ensuring that Novotech remains compliant and efficient in its global clinical trial operations. Overall, Zaiton’s comprehensive skill set and industry knowledge make her a vital asset in advancing clinical research initiatives worldwide.
Regulatory Start Up Manager at Novotech in May 2023 to Present
Senior Start Up Lead at Clinical Research Organization in May 2022 to February 2023
Clinical Trial Manager at ICON plc in March 2021 to April 2022
Regulatory Affairs Specialist at ICON plc in April 2018 to March 2021
SSU & Regulatory Specialist II at Syneos Health (Previously INC Research/inVentiv Health) in June 2012 to March 2018
Site Start Up & Regulatory Specialist II at INC Research in June 2011 to March 2018
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Good Manufacturing Practice (GMP)
Line Manager
Global Client Management
Site start-up till site activation
Presentation Skills
Managing Meetings
Weekly Report
Country Local Expert
Ethics submission
Veeva Vault
Project Planning
Line Management
Translation
Team Leadership
Communication
Medical Translation
Electronic Trial Master File (eTMF)
Clinical Trials
Clinical Research
Regulatory Affairs
Pharmaceutical Industry
CRO Management
Clinical Development
Clinical Trial Management System (CTMS)
Good Clinical Practice (GCP)
Oncology
Regulatory Submissions
Standard Operating Procedure (SOP)
Medical Devices
Regulatory Reporting
Contract Negotiation
Functional Management
Requirements Management
Project Management Office (PMO)
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Discover more about NovotechWhat is Zaiton S email address?
Email Zaiton S at [email protected] and [email protected]. This email is the most updated Zaiton S's email found in 2026.
How to contact Zaiton S?
To contact Zaiton S send an email to [email protected] or [email protected]. (updated on March 10, 2025)
What company does Zaiton S work for?
Zaiton S works for Novotech
What is Zaiton S's role at Novotech?
Zaiton S is Regulatory Start Up Manager
What is Zaiton S's Phone Number?
Zaiton S's phone (**) *** *** 505
What industry does Zaiton S work in?
Zaiton S works in the Pharmaceuticals industry.
Zaiton S Email Addresses
Zaiton S Phone Numbers
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