5 Regulatory Queries Jobs

As an Assistant General Manager (AGM) Formulation Development specializing in Injectable dosage forms, you will be responsible for the development, scale-up, and validation of both simple and complex formulations for Injectable products. Your primary focus will be on creating dosage forms compliant with regulations in the US, EU, India, Canada, Brazil, and other markets. Your key responsibilities will include: - Developing Injectable dosage forms for various global markets - Scaling up and transferring technology for Injectable products across different regions - Designing formulation strategies and overseeing the drug product development roadmap - Reviewing stability data of products under development and during validation batches - Handling regulatory queries and conducting studies as necessary - Coordinating with internal departments and external vendors for drug product development - Troubleshooting product and process failures, particularly for US, EU, and other markets - Providing technical guidance to subordinates and ensuring compliance with laboratory practices and safety regulations - Following Good Documentation Practices and Data Integrity requirements during GxP operations - Ensuring understanding and adherence to Data Integrity requirements and consequences - Reviewing data for compliance with Data Integrity requirements in the context of job responsibilities Your role will be crucial in ensuring the successful development and validation of Injectable dosage forms for multiple markets, requiring strong technical expertise, regulatory knowledge, and attention to detail.,

J.P. Morgan Liquidity & Account Solutions (L&AS) caters to global clients with intricate cash management requirements, spanning various countries, currencies, legal entities, and time zones. Clients include multinational corporations, high-growth technology firms, commercial banks, non-bank financial institutions, central banks, and broker-dealers. Our comprehensive solutions leverage physical, notional, and virtual techniques to empower clients in attaining visibility, control, and optimization of their working capital. As a Product Manager within Liquidity and Account Solutions (L&AS), you play a pivotal role in supporting the transformative agenda of Account Solutions Core Services on a global scale. Your responsibilities encompass designing operating models for optimization, understanding client business models, addressing client and regulatory inquiries, and overseeing deal reviews. Collaboration with Product Management, Sales, Technology, Operations, Legal, and Compliance teams is essential to foster robust partnerships. Your key responsibilities include leading various activities such as ultimate beneficiary visibility, VS deal reviews, legal document negotiations, product support for technical development, and issue investigations. You will analyze product performance metrics to drive strategic decision-making, manage day-to-day operations of Account Solutions products, and support the automation strategy. Collaboration with cross-functional teams to identify solutions aligning with client needs and business objectives is crucial. Furthermore, you will lead planning sessions, contribute insights, and ensure the successful delivery of product initiatives within set timelines. In this role, you will also be tasked with developing and implementing the L&AS product strategy and roadmap, maintaining risk & control frameworks, and partnering with stakeholders to provide guidance, analysis, and facilitate communication across impacted teams. **Required Qualifications, Capabilities, and Skills:** - Extensive experience in product management or Financial Services - Consulting/Strategy. - Proven track record in product life cycle activities encompassing discovery and requirements definition. - Exceptional organizational skills with the ability to manage multiple priorities under strict deadlines. - High level of initiative and a demonstrated aptitude for collaboration and partnership building. - Excellent analytical, problem-solving, and quantitative skills with the capability to comprehend complex regulations and legal documentation. - Proficiency in PowerPoint and Excel with acute attention to detail. - Strong written and verbal communication skills, including crafting executive-level communications. **Preferred Qualifications, Capabilities, and Skills:** - Advanced knowledge of data analytics and data literacy.,

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products that cater to the needs of underserved patients. With a focus on delivering unique, accessible, and high-quality medications, Azurity utilizes its integrated capabilities and extensive partner network to continuously broaden its diverse commercial product portfolio and robust late-stage pipeline. The company's patient-centric products encompass various therapeutic areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. For more information, please visit www.azurity.com. Azurity Pharmaceuticals takes pride in fostering an inclusive workplace environment and is committed to being an Equal Opportunity Employer. The success of Azurity is attributed to its exceptionally talented and dedicated team, which is driven by the mission of enhancing patients" lives through a combination of cutting-edge science and unwavering commitment to quality. We are looking for individuals who are highly motivated, possess integrity, and embody a creative spirit to excel in our organization. The Analytical Development department within the science organization at Azurity Pharmaceuticals plays a crucial role in developing new analytical methods for novel dosage forms to ensure product quality. Responsibilities: - Develop analytical methods for product development, primarily focusing on sterile dosage forms and/or oral dosage forms. - Prepare method development reports, validation protocols and reports, as well as test methods. - Perform routine analytical testing for assigned projects according to requirements. - Execute Analytical ATR (Analytical Testing Reports), document results, and communicate findings to the relevant formulation development (FD) team. - Calibrate assigned equipment, qualify working standards, and maintain standards based on storage conditions. - Conduct forced degradation studies and identify unknown impurities. - Conduct experiments to address and respond to regulatory queries. Qualifications And Education Requirements: - 6-8 years of experience in Analytical Development of Formulation. - M. Pharm or MSc in Chemistry. By applying for this role, you confirm that you possess the mental and physical capabilities necessary to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may impact your ability to perform the job, please inform HR in advance.,

As an Assistant General Manager (AGM) in Formulation Development for Injectable products, you will be responsible for the development, scale-up, and validation of simple and complex Injectable dosage forms for various markets including US, EU, India, Canada, Brazil, and others. This role is based at the Matoda plant in Ahmedabad. Your key responsibilities will include: - Developing Injectable dosage forms for multiple markets - Scaling up and transferring technology for Injectable dosage forms - Designing formulation strategies and drug product development roadmaps - Reviewing trials processes, development records, and technology transfer documents - Analyzing stability data of products under development and validation batches - Handling regulatory queries and conducting studies as required - Organizing resources, facilitating communication, and coordinating timely drug product development with internal departments and external vendors - Troubleshooting product issues and actively participating in failure investigations - Providing technical guidance to subordinates and ensuring adherence to good laboratory practices and safety regulations - Following Good Documentation Practices and Data Integrity requirements during all GxP operations - Ensuring understanding and application of Data Integrity requirements and consequences for non-compliance - Reviewing GxP data in compliance with Data Integrity requirements specific to the job description You may also be required to perform any other activities designated by your supervisor to support the overall objectives of the organization.,

The role involves managing the daily Profit and Loss (P&L) production and ensuring the integrity of Balance-Sheet Banking. Your responsibilities will include overseeing the daily P&L production and Balance-Sheet Analysis for Banking, managing accounting and reporting for various financial products, conducting new deal reviews and revenue recognition in compliance with IFRS9 & IFRS15. You will also be responsible for Net Interest Margin analysis, stakeholder engagement, representing Product Control in forums, ensuring adherence to controls and reporting processes, producing periodic MI packs with commentaries, and establishing best practices across processes. Additionally, you will review Key Control Indicators, support control & governance, handle external audits and regulatory queries, assist in new business initiatives, lead project delivery, and mentor the team. To qualify for this role, you should hold a CA or MBA in Finance from a reputable institution, along with at least 10 years of experience in banking finance. Standard Chartered is an international bank dedicated to making a positive impact for clients, communities, and employees. Our values focus on doing the right thing, continuous improvement, and working together towards long-term goals. We offer various benefits including core bank funding for retirement savings, medical and life insurance, flexible working options, proactive wellbeing support, continuous learning opportunities, and an inclusive work environment. If you are seeking a purposeful career with a bank that values diversity and inclusion, we encourage you to apply and be part of our team at Standard Chartered Bank.,