31 Regulatory Guidance Jobs - Page 2

ICON plc is a world-leading healthcare intelligence and clinical research organization that fosters an inclusive environment driving innovation and excellence. As the Senior Manager of Group Accounting & Reporting in the ICON Group accounting team, you will support internal and external reporting under US GAAP & IFRS. Your role will involve providing technical accounting leadership to the wider group finance teams and senior leadership teams. You will be responsible for preparing group annual reports under US GAAP & IFRS, as well as reporting quarterly financial information to the stock exchange under US GAAP. Additionally, you will prepare monthly consolidated group management information f...

Individuals in Quality Assurance, Monitoring & Testing are responsible for assessing outcomes from activities and processes against conformance with applicable requirements to strengthen risk management quality. This involves quality testing for business function quality control and transformation lead quality control post-completion of an activity/process. It includes the development and execution of Monitoring and Testing for controls, such as control design assessment, operational effectiveness design for monitoring & testing tools, monitoring/testing design assessment, and execution of monitoring/testing tools to assess the effectiveness of key controls designed to address defined risks....

Precision for Medicine is looking for a skilled Medical Coder to provide comprehensive Coding and related data management support during all phases of the clinical trial data management process. Working under direct supervision with a team of medical coders, you will ensure compliance with Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role involves various responsibilities, including data coding, quality review, and collaboration within a dynamic team environment. The Coder will be responsible for providing Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full-time basis. They will follow Standard Operating Procedures/Work...

Provide expert advice on product development, regulatory strategy, and market analysis to life sciences clients. Job Summary: We are seeking a knowledgeable Life Science Consultant to provide expert guidance on product development, regulatory strategy, and market analysis for clients in the life sciences sector. The ideal candidate will combine scientific expertise with strategic insight to deliver impactful solutions that drive innovation and business growth. Key Responsibilities: Advise clients on product development strategies and lifecycle management. Provide regulatory guidance and support for compliance with local and global standards. Conduct market research and competitive analysis t...

Are you looking for an opportunity to be part of a growing organization and work as part of a global team to drive strategy in a constantly changing environment We are looking for a professional with experience in the financial industry to join Business Data Intelligence Team in the Tax Department. Tax analyzes and supports the activities, operations, reporting obligations, and transactions of the firm's business lines to ensure that tax consequences and reputational risks are evaluated appropriately. The work directly contributes to the firm's success, making it ideal for creative and collaborative individuals who have strong ethics and attention to detail. The team is responsible for maint...

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corp...