6 Regulatory Guidance Jobs

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 for internal purposes and offer accounting and regulatory guidance on key issues impacting the business. Your expertise will be crucial in assessing the impact of new accounting standards/regulatory changes and leading a strong SOX control environment. Collaboration with internal customers and stakeholders to enhance processes & systems for financial reporting, supporting the integration of acquisition targets, and coaching junior team members are also part of your responsibilities. Your experience should include being a high-performing ACA, ACCA with a minimum of 7 years PQE, strong financial accounting background, and familiarity with US GAAP & IFRS. Effective communication, organizational skills, and the ability to manage multiple deliverables are essential. ICON offers competitive benefits including various annual leave entitlements, health insurance options, retirement planning, a Global Employee Assistance Programme, life assurance, and flexible country-specific optional benefits. If you require accommodation during the application process due to a medical condition or disability, please inform us. Even if you do not meet all requirements, we encourage you to apply as you may be the ideal candidate for this or other roles at ICON.,

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. Responsibilities: - Act as the EUC/ITeSS Delegate Accountable Business Owner for DART, reporting directly to the Accountable Business Owner (ABO). - Govern EUC Risk Reduction planning and ITeSS migration efforts, monitor the active control environment around registered EUCs and ITeSS Use Cases within DART. - Ensure EUC/ITeSS Champions and Owners understand their requirements under the EUC Policy and Standard. - Ensure quality, completeness, and accuracy of the implementation of the Control Framework, including Risk Control Policy, Control Standard, Issue Management Policy, Lesson Learned Policy, and Control Inventory. - Lead the assessment of activities and processes to strengthen risk management quality as per required Policies, Standards, and Procedures. - Conduct routine testing of internal activities and processes to ensure adherence to quality standards and identify areas of risk or non-compliance. - Review stakeholder/client feedback, respond to any quality assurance complaints or issues promptly. - Support quality testing for business function quality control and transformation lead quality control post-completion of an activity/process. - Drive the assessment of activities and processes to strengthen risk management quality. - Integrate stakeholder/client feedback and respond to quality assurance complaints or issues efficiently. - Oversee quality testing for business function quality control and transformation lead quality control post-completion of an activity/process. - Develop and execute Monitoring and Testing for controls, including control design assessment, operational effectiveness design for monitoring & testing tools, monitoring/testing design assessment, and execution of monitoring/testing tools. - Regularly report on quality control outcomes and control effectiveness to top management and relevant stakeholders. - Possess proficient knowledge of regulatory guidance specific to quality assurance and monitoring/testing lifecycle. - Appropriately assess risk in business decisions, considering the firm's reputation and safeguarding Citigroup, its clients, and assets by driving compliance with applicable laws, rules, and regulations. Qualifications: - 12+ years of experience in operational risk management, compliance, audit, or other control-related functions in the financial services industry. - Background and/or familiarity with Regulatory and Management Reporting processes and their control environment. - Project Management Experience, ability to identify, measure, and manage key risks and controls. - Track record leading Control related projects and programs, ability to see the big picture with high attention to critical details. - Comprehensive knowledge of Citigroup's businesses and functions, developing new ideas and improving current processes to mitigate risks proactively. - Expert knowledge in the development and execution of controls, proven experience in control-related functions in the financial industry. - Strong leadership, decision-making, problem-solving, analytical, and communication skills. - Ability to deliver compelling presentations, influence executive audiences, a sense of accountability, and ownership. - Excellent familiarity with Microsoft Office suite, particularly Excel, PowerPoint, and Word. Education: - Bachelor's/University degree, Master's degree preferred.,

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 Instructions (SOPs/WIs), regulatory directives, and study-specific plans and guidelines. This position involves performing Coding quality reviews and working closely with the Coding Manager to prioritize coding tasks for timely completion. Key responsibilities of the job include but are not limited to: - Conducting medical coding of medical terms to ensure logic and consistency (MedDRA and WHODRUG) - Supporting other team members as needed, ensuring tasks are completed promptly - Performing quality control of Coding - Providing input into Coding timelines for overall deliverables - Meeting clinical data coding deadlines with quality - Reviewing feedback from stakeholders - Conducting coding dictionary upgrade UAT and maintaining quality-controlled documentation - Creating, revising, versioning, and maintaining data management coding documentation - Training clinical research personnel on study-specific Coding related items - Reviewing and querying coding data as per the Data Management Plan and Coding standards - Running coding status and metric reporting - Assisting in the development and maintenance of SOPs and process documentation related to coding activities - Ensuring all team members have received sufficient training - Communicating with study sponsors and project teams as required - Conducting coding demonstrations/trainings and participating in department/company training sessions and project meetings - Performing other assigned duties Requirements: - Minimum of 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - At least 2 years of experience in performing Dictionary medical coding (MedDRA and WHODrug) - Proficiency in Microsoft Office applications - Strong organizational and communication skills - Basic knowledge of drug, device, and/or biologic development and data management practices Preferred Qualifications: - Experience in a clinical, scientific, or healthcare discipline - Oncology and/or Orphan Drug therapeutic experience Skills: - Demonstrated knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance - Ability to implement and drive outcomes Precision Medicine Group ensures that any data provided as part of the application process will be stored in accordance with its Privacy Policy. For CA applicants, please refer to the CA Privacy Notice. Individuals with disabilities requiring accommodations during the application process may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. Please note that the organization follows a formal interview process and communicates directly with candidates before extending a job offer to prevent fraudulent activities by unauthorized individuals or organizations.,

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 to inform client decisions. Support innovation initiatives and facilitate workshops or training sessions. Prepare detailed reports, presentations, and recommendations for clients. Collaborate with cross-functional teams to ensure project success. Key Performance Indicators (KPIs): Project success rate and timely delivery Client satisfaction and feedback scores Number and effectiveness of workshops conducted Measurable impact of recommendations on client projects Skills & Competencies: Strong understanding of life sciences, pharmaceutical, or biotech industries Expertise in regulatory affairs and product development Analytical thinking and problem-solving skills Excellent communication and presentation abilities Ability to manage multiple projects and clients simultaneously

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 maintaining the integrity of the firm's compliance with reporting authorities globally and managing related inquiries from various businesses across established and emerging markets. Daily functions include accurate account documentation, withholding, client information reporting, and regulatory filings. The team also provides subject matter expertise and support during the design, testing, and implementation of related systems and processes. There are opportunities to optimize procedures and build scalability through data analytics and efficient technology use. In this role, you will have high visibility and work with senior management and teams across regions to drive initiatives and issue resolution. You will develop expertise in relevant tax systems, procedures, and requirements, gaining a comprehensive understanding of multiple business lines across the firm. Your inquisitive mindset will help identify control weaknesses, mitigate risks, improve timeliness in regulatory reporting, and enhance process automation. You will act as a risk manager by assessing the tax regulatory environment and the firm's adherence to tax reporting obligations. Your responsibilities will also involve representing Tax in firm-wide technology projects, troubleshooting current applications, creating operational procedures, and collaborating with key stakeholders. You will help teams adopt a documentation-driven development model and identify opportunities for process improvements and technology best practices. Basic Qualifications: - Bachelor's degree and 4+ years of relevant work experience in Math, Computer Science, Operations, Accounting, Finance, or related field leading teams, functions, and projects. - Excellent Communication Skills and ability to prioritize workload, solve problems, and take accountability for deadlines and outcomes. - Proven leadership abilities, with skills in leading through influence, building consensus, and managing senior/executive-level stakeholders. - Ability to work in project teams and across products, regions, and functions in the financial services industry. - Strong people management skills, collaboration, and consensus-building capabilities. - Ability to remain composed under pressure, prioritize tasks, and make decisions in a fast-paced environment with a risk mindset. Preferred Qualifications: - Strong data analysis skills and experience with Microsoft Excel, SQL, Alteryx, Python, User Testing, Visio, JIRA. - Experience in decision modeling, process transformations, writing technical and functional requirements, root cause analysis, and UAT testing. - Exposure to programming languages such as Java, C++, Python, and AI / LLM. - Knowledge of Corporate Tax, Finance functions, Financial Services, and Banking Industry. - Previous Tax-related work experience in translating regulatory guidance into systematic solutions for risk mitigation and compliance mandates.,

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, corporate quality audit, and CMO site on manufacturing and technical matters. Additionally, you will be involved in authoring and reviewing quality agreements, ensuring the use of qualified service providers, participating in process validation batches, reviewing quality system documents, conducting visits based on market complaints/recalls/CAPA, reviewing batch records, stability data, and analytical reports, as well as preparing and reviewing SOPs. Your role will also include participation in the initial evaluation of CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, initiating QMS documents, preparing for regulatory agency inspections, participating in product release site audits, maintaining audit-related documents, preparing monthly reports, staying updated on regulations through training, and following Corporate Quality Policies/Global Quality Standards and Regulatory Guidelines. To be successful in this role, you should have an M.Sc./B.Pharm/M.Pharm or equivalent degree along with a total of 10 years of industrial experience and knowledge. You will also be expected to participate in and execute project work assigned by your reporting authority. If you are looking for a challenging opportunity to ensure quality compliance in contract manufacturing organizations and contribute to the overall quality standards of SUN Pharma, this role is ideal for you. Join us in our mission to maintain high-quality standards and regulatory compliance in the pharmaceutical industry.,