Jain
Global Regulatory Submission Management Professional | Senior Analyst @ IQVIA | Project Management, Submission Management, Regulatory Intelligence, Operational Specialist
- Role
- Senior Analyst - Regulatory Intelligence at IQVIA
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Jain
Seeking to transition into an entry-level leadership role where I can apply my regulatory…
Experience
Senior Analyst - Regulatory Intelligence
Dec 2024 — Present · Bengaluru, IN
Prepares, reviews, and updates regulatory documentation around clinical trials based on documents published by regulatory authorities as appropriate with particular focus on the US, Canada, Puerto Rico, Spain and Australia.• Conduct Regulatory Intelligence (RI) by systematically gathering, analyzing, and interpreting regulatory information from health authorities to ensure compliance and competitiveness in the life sciences industry.• Collaborates with cross-functional teams—including Strategists, submission management, and a network of internal and external regulatory experts—to ensure the implementation of high-quality standards and the latest industry guidance, maintaining excellence in dossier quality.• Leading and participating in Scientific Advisory Committee (SAC) meetings to independently prepare and maintain detailed documentation, including background analysis reports, briefing summaries, final result wire reports, and decision reports. • Offering expertise on clinical trials, including pre-approval and post-approval phases, to address inquiries from clients, sales teams, marketing, and business development. • Acting as a subject-matter expert in Regulatory affairs related to clinical trials, including CTAs and INDs, while effectively managing workload and responsibilities.• Guides colleagues, providing feedback on the quality of technical documents and assisting in their training and development.
Education
Model Higher Secondary School
Higher secondary
2012 — 2013
Gyan Bharti Convent Higher Secondary School
High school
2010 — 2011
VNS Group of Institution,VNS Campus, Vidya Vihar, Nathu Barkheda, Neelbud, Bhopal-462044
Bachelor of Pharmacy
2013 — 2017
Lakshmi Narayan College of Technology, Sanwar Road, Indore
Master of pharmacy
2017 — 2019
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