LifeScience Regulatory Svs Analyst

Role Overview: You will be a LifeScience Regulatory Services Analyst at Accenture, aligned with the Life Sciences R&D vertical. Your responsibilities will include performing regulatory affairs tasks such as submission in accordance with ICH guidelines and other Health Authorities, reviewing and transforming Source Documents, performing Quality Control (Document QC) checks for all submission components, and collecting, collating, and evaluating scientific data gathered as part of R & D. Additionally, you will advise on legal and scientific restraints and requirements to ensure the organization's products comply with current regulations. Key Responsibilities: - Perform regulatory affairs tasks including submission in accordance with ICH guidelines and other Health Authorities - Review and transform Source Documents - Perform Quality Control (Document QC) checks for all submission components - Collect, collate, and evaluate scientific data gathered as part of R & D - Advise on legal and scientific restraints and requirements to ensure compliance with current regulations - Build regulatory submission strategy, author CMC documents, and health authority packages Qualifications Required: - Master of Pharmacy Additional Company Details (if present): Accenture is a global professional services company with leading capabilities in digital, cloud, and security. With over 699,000 employees serving clients in more than 120 countries, Accenture offers Strategy and Consulting, Technology and Operations services, all powered by the world's largest network of Advanced Technology and Intelligent Operations centers. Accenture embraces the power of change to create value and shared success for clients, people, shareholders, partners, and communities. Visit www.accenture.com for more information.,