14 Nov
|
Iqvia
|
Bengaluru
IQVIA seeks a Regulatory Affairs Manager in Bangalore to lead complex regulatory projects independently, manage stakeholder relationships, and provide technical guidance to junior staff. The role requires advanced expertise in drug development regulations and marketing authorization processes.
Responsibilities
Lead complex regulatory projects and act as technical project manager with minimal senior oversight
Prepare regulatory and technical documents with limited review requirement from senior staff
Establish and maintain client relationships; present regulatory strategy and lessons learned
Manage project budgets, revenue recognition, and out-of-scope activity oversight
Mentor junior colleagues on document quality and provide training and development guidance
Requirements
Bachelor's degree in life sciences or related field; Master's preferred
Minimum 8 years of relevant regulatory affairs experience
Deep knowledge of R&D; processes, CMC, preclinical, and clinical regulations
Demonstrated expertise in marketing authorization transfer and regional regulatory procedures
Project leadership experience with proven ability to manage timelines and budgets
Solid client relationship management and cross-functional collaboration skills
Proficiency in Microsoft Office and regulatory publishing software
📌 Regulatory Affairs Manager - Opportunity for Growth! (Bengaluru)
🏢 Iqvia
📍 Bengaluru