Job Description

IQVIA Regulatory Intelligence provides instant access to regulatory insights and real-time updates from national authorities across the globe, helping you to avoid the resource-intensive process of gathering, organizing, and sharing important regulatory information. IQVIA Regulatory Intelligence services cover more than 110 countries, regions, and international organizations. IQVIA RI supports pharmaceutical and medical device companies by providing access to up-to-date and comprehensive original and translated regulatory documents, expert country summaries, tabulated comparative regulatory information covering operational details and timely alerts with state-of-the-art functionality.OVERVIEW OF ROLE:Based in our India office (Bangalore / Gurgaon), We seek a skilled Individual contributor proficient in applying subject matter expertise. The successful candidate will be responsible for the creation and upkeep of high-quality regulatory intelligence content focusing on Clinical Trial Data.RESPONSIBILITIES

• Prepares, reviews, and updates regulatory documentation in the area of clinical trials based on documents published by regulatory authorities as appropriate with particular focus on the US and Canada.
• Works within cross-functional teams and collaborates with a network of internal/external regulatory experts to ensure the production and maintenance of high-quality (timeliness, completeness, and accuracy) regulatory intelligence related to clinical trials, as per defined quality processes.
• Performs quality control activities of external expert contributions within the area of clinical trials.
• Provides knowledge related to clinical trials to support inquiries from customers, sales, marketing, and business development.
• Acts as a subject matter expert of Regulatory knowledge in clinical trials as applicable.
• Understands the scope of work, deliverables, and manages workload as appropriate.
• May give guidance to colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• May conduct and present regulatory training sessions for small groups or individuals within the RI team.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Proven experience and tenures working in Clinical Trials within Life Sciences (within regulatory authority, consultancy, or industry) in the APAC region, United States and Canada.
• Preferred hands-on experience in clinical trial submissions in the APAC Region, United States and Canada.
• Degree in life sciences and supplementary education with a clinical trials component would be an advantage.
• In-depth knowledge on clinical trial regulatory including:

o Requirements in all phases of drug development (phase I-IV studies)
o Clinical trial applications to regulatory agencies and ethics committees
o Regulatory processes and approval times
o Knowledge of clinical trial registries and results disclosed.
o Ability to assess impact of new regulatory requirements.

• Ability to understand and interpret regulatory developments (guidelines, regulations, and laws) to understand, anticipate, interpret, and communicate regulatory trends and requirements.
• Prior knowledge in biologics would be an added advantage. Familiarity with biological systems, processes, and terminologies will also be beneficial.
• At least 4-5 years relevant experience
• Ability to communicate clearly and effectively (verbally and written) and experience in writing summaries/reports for different audiences.
• Strong attention to detail, proactive and highly organised.
• Knowledge of quality management within Life Sciences.
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable.
• Demonstrates self-motivation and enthusiasm.
• Ability to work on several projects, with direction from senior staff as appropriate.
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.
• Ability to adapt quickly to a rapidly changing environment.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible \xe2\x80\x93 to help our customers create a healthier world. Learn more at

IQVIA