1444 Ich Jobs - Page 15

About Zscaler Serving thousands of enterprise customers around the world including 45% of Fortune 500 companies, Zscaler (NASDAQ: ZS) was founded in 2007 with a mission to make the cloud a safe place to do business and a more enjoyable experience for enterprise users. As the operator of the world’s largest security cloud, Zscaler accelerates digital transformation so enterprises can be more agile, efficient, resilient, and secure. The pioneering, AI-powered Zscaler Zero Trust Exchange™ platform, which is found in our SASE and SSE offerings, protects thousands of enterprise customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Named...

Role Description: The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: With support, advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Lia...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

What you will do The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization. The AVP will lead Amgens Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases. This AVP will collaborate closely with cross-functional teams including clinical operations, ...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities

Role description: Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this important, product-facing role you will lead assigned Global Regulatory Teams (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Associate Director is to lead GRTs within Amgens GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements, maintai...

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates a...

What you will do In this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety documents, across therapeutic areas and for biosimilars (mandate) Write other regulatory submission documents (eg, RTQs, PIP, white papers, breakthrough therapy...

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgens CMC submission execution team, R egulatory O ptimization o f T actical and S trategic S upport (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC t...

Position title: ESO QA Specialist University degree in Pharmacy, Chemistry, Biology, or relevant Life Science Minimum of 5 years in a similar role or equivalent experience in a GMP-related environment Job location - Ankleshwar, Gujarat, India MISSION STATEMENT To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor. Main Accountabilities And Duties Operational skills Operational quality management of a dedicated product portfolio which includes: Quality management of deviation and complaint records and their related CAPAs Assessment and management of change controls Edition of QA Agreements with Zentiva third parties and subcontractors Co...

Location - All India - Delhi, Mumbai, Pune, Bangalore, Kochi, Chennai, Hyderabad, Ahmedabad, Bhopal, Indore, Kolkata, Chandigarh Role & responsibilities Handle, organize, and maintain clinical, medical, and healthcare project documentation. Accurately enter and validate healthcare and research data in internal systems. Review medical case records, lab reports, and related documentation for completeness. Collaborate with research, operations, and regulatory teams to gather required information. Prepare, format, and update reports for ongoing research and healthcare projects. Track timelines for documentation deliverables in line with project schedules. Maintain data confidentiality and adhere...

Role Overview: Tradeweb is looking for a trade surveillance officer, based in Bengaluru, to provide trade surveillance coverage across Tradewebs European trading venues. The European trade surveillance team monitors and analyses the trading activity of all participants across the Tradeweb European platform. Surveillance utilises and develops electronic tools and integrative techniques to detect potential and/or actual violations of regulatory requirements, and works in close partnership with the wider Compliance team, Technology, Business Managers and various groups across the firm to ensure that Tradewebs markets remain clean and orderly. To succeed in this role, you will need to be a team-...

We are looking for a highly experienced and skilled finance professional to lead our financial team as a Director-Finance at Marriott International. The ideal candidate will have a strong background in finance and accounting, with excellent leadership and management skills. Roles and Responsibility Oversee the development and implementation of financial strategies to drive business growth. Manage and analyze financial data to inform business decisions and optimize performance. Lead and manage a team of finance professionals, providing guidance and support. Develop and maintain relationships with external stakeholders, including auditors and bankers. Ensure compliance with financial regulatio...

Job Summary Payroll Specialist is responsible for executing the organization's payroll activities, ensuring pay is processed on time, accurately and in compliance with government regulations. This role involves payroll, aiding in data gathering, assisting in ad hoc projects and additional payroll works when required. Job Requirements EMEA Based payroll experience is required. Payroll Processing: Work with vendor for preparation and distribution of the company's payroll, ensuring accurate and timely processing of payroll transactions including salaries, benefits, taxes, and other deductions. Compliance: Ensure compliance with as per the government legislation requirements. Stay updated on cha...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Role Objective A key objective of this position is to serve as a strategic leader by providing scientific, technical, and managerial expertise in Quality Control (QC) and Analytical Development across diverse product portfolios. The position is responsible for establishing, validating, and implementing robust analytical testing methodologies in alignment with global regulatory requirements. In addition, the role emphasizes driving operational excellence, ensuring regulatory compliance, and fostering a culture of continuous improvement within the organization. Desired Candidate Profile Graduate/Postgraduate in Life Sciences, Pharmacy, Biotechnology, or a related field. Minimum 1822 years of r...

Ensure the integrity of data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and internal SOPs Prepare and maintain documents related to clinical trials. Generate data entry queries and test clinical applications for numerous clinical trials. Analyze clinical trials data and prepared reports for Data Coordinator and Sponsor. Serve as liaison between Data Management and other departments in Clinical application developments. Manage clinical research data for the new and ongoing electronic clinical trials. Conduct UAT Testing and validate software application processes for the management of clinical trials. Assist with the creation of data man...

We are seeking a highly experienced and driven Global Process Owner to lead the transformation of our Order to Cash (O2C) processes within our finance and accounting function. The successful candidate will be responsible for driving the analysis, design, and implementation of process improvements across multiple business divisions and regions, including the Americas, EMEA, and APAC. This role requires a strong leader who can influence, and impact work delivered from multiple centers across US and Chennai, India, and collaborate with multiple senior stakeholders at the client end. Lead the transformation of the O2C process, focusing on optimizing efficiency, reducing costs, and enhancing cust...

Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking->GPP Financial Services Domain->Payments->GPP Generic Skills: Banking Roles and Responsibility Manage and process payments transactions efficiently. Collaborate with cross-functional teams to resolve payment-related issues. Develop and implement new payment systems and processes. Analyze payment trends and provide insights for improvement. Ensure compliance with regulatory requirements and industry standards. Provide excellent customer service and support to clients. Job Requirements Strong knowledge of payment processing and reconciliation. Experience with payment gateways and payment system...

Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufact...

As a Clinical Development Manager at Azurity Pharmaceuticals, you will play a crucial role in supporting departmental activities related to clinical trials and scientific analyses across therapeutic areas. Reporting to the Associate Director, Clinical Development, you will have the opportunity to contribute to the success of the organization by leveraging your expertise and skills. Your responsibilities will include but are not limited to: - Ability to understand integrated data from clinical trials and other sources to provide scientific evaluations and develop risk assessments. - Providing operational and scientific oversight of nonclinical and clinical studies, ensuring compliance with GC...

We are looking for a skilled HSE Officer to join our team in the international sector. The ideal candidate will have 3-7 years of experience in the field. Roles and Responsibility Develop and implement effective health, safety, and environmental management systems. Conduct regular audits and inspections to ensure compliance with regulatory requirements. Provide training and guidance on health, safety, and environmental procedures. Investigate incidents and accidents to identify root causes and implement preventive measures. Collaborate with other departments to develop and implement emergency response plans. Maintain accurate records of health, safety, and environmental performance metrics. ...

Heres how youll contribute: Writing skills, specifically around describing a scene and driving logic Fluent in English language, familiarity with road signs in the US (Other regions including EU is a bonus) AV labeling experience (bounding boxes, etc) College Educated