Reg Affairs Officer 2 (R1064803) in Bangalore, India at IQVIA™

Date Posted: 8/8/2019

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Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

• Degree in life science-related discipline or professional equivalent
• Minimum of 4 years in regulatory CMC experience, focusing on marketed products
• Experience of product development/manufacturing or analytical work is strongly preferred
• Experience in regulatory procedures in Europe and/or emerging markets (e.g. variations/renewals/aggregate reports)
• Experience in new MAA applications in Europe and/or emerging markets an advantage
• Understanding of the content and typical level of detail in Module 3. 
• Experience in conducting CMC Change Control Assessment – determine if regulatory action is required and if so determine the strategy, documentation requirements and timelines;
• Provides regulatory strategy of CMC submissions worldwide
• Preparation of technical justifications to support variations in collaboration with technical experts
• Manage own work load, tracks project timelines, implements client requests and manages day-to-day workload.
• Prepare and review Module 3 CTD sections for regulatory submissions (variations, renewals, responses to RA assessments); 
• Experience in quality review of technical/ regulatory documents
• Able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1064803