Jude Stephen
Regulatory Affairs Manager @ IQVIA
- Role
- Regulatory Affairs Manager at IQVIA
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Jude Stephen
I am an experienced professional with over 10 years in Regulatory Science for Biologics Development and healthcare consultation across ICH regions. Currently pursuing an MBA in General Administration, I am eager to transition into broader organizational management roles. My expertise lies in process coordination, documentation, and compliance management, ensuring that operations run smoothly while adhering to both internal policies and external regulatory requirements. I have a strong background in project management, reporting, and stakeholder communication, which has enabled me to streamline workflows and support data-driven decision-making.Throughout my career, I have demonstrated my ability to work effectively in multicultural, cross-functional teams, fostering knowledge sharing and continuous improvement initiatives. My key achievements include successfully contributing to major product milestones, such as IND submissions for the US FDA and Health Canada, and the development of four new products targeting cancer, diabetes, and immune diseases. I am knowledgeable in resource planning, data management, and policy implementation, which has significantly contributed to operational efficiency and cost optimization.
Experience
Regulatory Affairs Manager
Feb 2026 — Present
Education
Indian Statistical Institute(SQC & OR)
Diploma, statistical quality control
New prince matriculation
SRM university, Chennai, Amity University, UP, India
2004 — 2009
Amity University
Master of Technology (M.Tech.), Biotechnology
2013 — 2015
SRM IST Chennai
Bachelor in technology, Genetic engineering
Indian Institute of Management, Indore
Master of management studies, Business Administration and Management, General
Indian Institute of Management, Indore
Executive MBA, Business Administration and Management, General
Skills
- Cell Culture
- Bioinformatics
- Teamwork
- Biochemistry
- Microbiology
- Life Sciences
- Cell Biology
- Sds-Page
- Outlook
- Reverse Phase Hplc
- Zebra Fish Behavior Studies
- Ich Guidelines
- Biotechnology
- Research
- Western Blotting
- Api Purification
- Molecular Biology
- Polymerase Chain Reaction (Pcr)
- Microsoft Office
- Customer Service
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