9 Regulatory Expectations Jobs

Role Overview: You will be joining the Model Risk Management Group (MRMG) as a Senior Consultant, Risk Analytics at Northern Trust. Your primary responsibility will be to lead the discovery and diagnostic of AI/ML model related risks, including various aspects such as input data, assumption, conceptual soundness, methodology, outcomes analysis, benchmarking, monitoring, and model implementation. Key Responsibilities: - Independently validate Artificial Intelligence (AI), Machine Learning (ML), and Generative AI (GenAI) models, covering supervised, unsupervised, reinforcement learning, and foundation model categories. - Evaluate Gen AI model risk, including aspects like hallucination, prompt ...

Role Overview: You are being hired as a Sr Specialist Advanced Analytics Americas DTO at Mitsubishi UFJ Financial Group, Inc. (MUFG) to be a part of the Global Financial Crimes Division (GFCD) Operations function. Your main responsibility will be to lead the Operations Intelligence & Analytics capabilities, focusing on enhancing the effectiveness, efficiency, and risk mitigation capabilities of the Transaction Monitoring DTO program specifically for the American region. Key Responsibilities: - Provide strategic direction and day-to-day leadership to a team of analysts and specialists. - Oversee threshold tuning, rules optimization, and filter platform enhancements to improve Transaction Moni...

Role Overview: You will be responsible for product development activities of all injectable dosage forms for regulated markets including General injectable, Onco, and Peptide products. You will need to have a good understanding of ANDA and 505b2 product filing, as well as exposure to a wide range of dosage forms such as liquid solution, lyophilized, and suspension. Your role will also involve understanding Drug device combination products and regulatory expectations. You will be experienced in preparing and reviewing product development reports, MFR, stability protocols, study protocols, SOPs, and have a basic understanding of implementing QbD principles for formulation development. Key Resp...

Job Title: Sr. Executive / Assistant Manager Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 8 to 10 years of similar experience in a regulatory-approved OSD manufacturing large unit. Job Responsibilities & Accountabilities We are looking for an experienced QA professional to join our team and lead Deviation & Complaint Investigations, along with core QMS activities. Key Responsibilities Lead deviation and market complaint investigations, with timely CAPA execution Ensure effective implementation and tracking of CAPAs from deviations & complaints Review Batch Manufacturing & Packing Records, APQR, and SOPs Manage Change Controls, V...

Job Purpose Under the guidance of senior management, the IT General Control Testing Lead will be responsible for overseeing the planning and execution of IT General Controls (ITGC) testing. This includes the collection and review of evidence, coordination with service owners and Allianz Technology (AZ Tech) for any missing documentation, and ensuring timely delivery of ITGC control testing Key Responsibilities Lead the planning and execution of ITGC control testing, including evidence collection, review, and follow-up with service owners and AZ Tech for any missing documentation. Manage the delivery of ITGC control testing to meet agreed deadlines. Coordinate the annual ITGC control testing ...

Key Responsibilities Design and execute peptide synthesis processes (SPPS / solution phase / hybrid approaches) for API development. Optimize reaction conditions, resin selection, coupling strategies, and cleavage protocols to achieve high yield, purity and productivity. Develop and validate purification processes (prep HPLC/UPLC, crystallization, lyophilization). Conduct analytical characterization of intermediates and final peptide APIs using HPLC, LC- MS, NMR, FT-IR and other relevant techniques. Support process scale-up from lab to pilot/plant scale, ensuring reproducibility and regulatory compliance. Prepare process development reports, technology transfer documents, and regulatory subm...

Join us as a GTSM Markets - Risk & Control Lead at Barclays, where you will play a pivotal role in spearheading the evolution of our GTSM function. Your primary responsibility will be to maintain our maturity on various risk and control metrics (KRP, KPI, and DCs) to ensure Application Stability & Reliability. Collaborating for controls implementation, monitoring, and reporting will be key aspects of your role, ensuring that operational processes and technology services align with our risk appetite. By translating the risk & control framework into day-to-day service delivery activities, you will track and report control health metrics and maintain dashboards for stakeholders and regulatory s...

The Technology Transfer Associate is responsible for coordinating and executing the seamless transfer of pharmaceutical products to Ritsa manufacturing Facility from client /R&D or result in any merger or acquisition. This role will oversee the planning, execution, and completion of projects with end-to-end accountability for deliver in time This role ensures that all processes (analytical and manufacturing) are effectively transferred while maintaining compliance with regulatory requirements, quality standards, and operational efficiency. Key Responsibilities: Project Planning and Execution Define project scope, objectives, deliverables, and timelines. Develop detailed project plans, alloca...

The lead Program Management, Small Molecules position is responsible for establishing and providing overall leadership in project management for small molecules technology (SMT) and Analytical technology (AT) in Chennai, as well as supporting the management of OpEx and CapEx budgets. This role also involves supporting Stores & Logistics for the synergy site. You will provide leadership to the Project Management team by defining clear, realistic goals, removing barriers to ensure team progress, and facilitating rapid decision-making. Additionally, you will facilitate resolution and appropriate escalation of conflicts within the team and with other stakeholders to ensure project success. Manag...