Radha Joshi
Senior Regulatory Affairs Specialist @IQVIA
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WORK HISTORY
Senior Regulatory Affairs Specialist @IQVIA
Bengaluru, IN
Act as the global regulatory lead for assigned products across development and marketed lifecycle. • Develop and implement regulatory strategies for EU, UK, and Health Canada submissions. • Lead preparation, review, and submission of regulatory dossiers including initial submissions, amendments, and responses to agency queries. • Ensure compliance with EU CTR, UK MHRA, and Health Canada regulations, guidelines, and timelines. • Serve as primary liaison with EMA, MHRA, and Health Canada regulatory agencies; represent company in meetings. • Provide strategic input to cross-functional teams (Study Start Up, Clinical, Safety, Project Management, Quality). • Drive global regulatory alignment across regions, ensuring consistency in strategy and messaging. • Identify regulatory risks and propose mitigation strategies to stakeholders and senior management. • Monitor changes in regulatory requirements, assess impact, and communicate to teams proactively. • Support regulatory intelligence gathering and competitor landscape assessments. • Contribute to global submission planning tools, project timelines, and resource forecasts. • Mentor/guide junior regulatory team members and provide training on EU/UK/Canada regulations.
EDUCATION
Don Bosco High School - India
Gujarat Higher Secondary Education Board
Babria Institute of Pharmacy, Gujarat Technological University (GTU)
Bachelor of Pharmacy (B.Pharm.)
National Institute of Pharmaceutical Education and Research
Master of Science (M.S.)
Silver Oak School - India
Gujarat Secondary Education Board
SKILLS
ABOUT RADHA JOSHI
Global Regulatory | CMC | Biologics |10+ years in Drug Development
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