Regulatory Coordinator

**About the Role**: Your responsibilities include, but are not limited to: - Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations - Contribute to Module #1...

Your responsibilities include, but are not limited to:• Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations• Contribute to Module #1 documents including FDA...

CTD Dossier Drafting (Modules 2, 3, 4) - Regulatory writing - Clinical Regulatory & Pharmacovigilance Regulatory - Regulatory commitment & compliance - Any other Regulatory activities on need basis - Support Line manager & Matrix manager in Regulatory projects - Coordination and interaction with cross-functional teams Mandatory Skills Effective...

**Positions**: **Executive and Sr. Executive** FSSAI Product Registration - 1.Dossier Compilation as per country guidelines. 2. Labeling compliance - Review or validation of Label Artworks, RDA values Claims, etc. Review of Pre-Formulation composition and Final formulations compositions as per FSSAI norms and provide the various possible formulations...

**Summary**: To support and ensure consistency and implementation of assigned Third Parties change projects from initiation to execution end to end, in order to ensure timely implementation of changes and supply to the markets in compliance with regulatory and cGMP requirements. **About the Role**: Position Title : ESO Change Coordinator - Location -...

**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

Your responsibilities include but not are limited to:• Regulatory Strategy -Responsible for implementing regulatory strategy and managing operational activities for assigned regions.Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or...

About the job The Regulatory Innovation Associate plays a critical role in the development of regulatory services technology products to drive innovation and differentiation. Under general supervision, provides regulatory expertise and technical support for regulatory technology innovation initiatives. Essential Functions: Navigate through the Health...

**About this Role**: The Due Diligence Coordinator conducts due diligence and investigations on commercial customers and their related parties (owners, board of directors, and chief level executives), as well as the bank high net value clients seeking to expand or establish new credit relationships. Primary due diligence and investigative responsibilities...

**About this role**: Wells Fargo is seeking a Business Accountability Coordinator. **In this role, you will**: - Conduct comprehensive research and background reviews of transactions, individuals, entities, organizations or locations to identify and mitigate risks through documenting findings and escalation. - Research business escalations to review...

Regulatory Affairs LabelingBachelor's Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)The...

We are seeking a motivated and detail-oriented Clinical Research Coordinator to join our dynamic team. As a Clinical Research Coordinator, you will play a crucial role in the planning, implementation, and coordination of clinical research studies. You will work closely with principal investigators, study participants, and other healthcare professionals to...

About thejobThe Regulatory InnovationAssociate plays a critical role in the development of regulatoryservices technology products to drive innovation anddifferentiation.Under general supervisionprovides regulatory expertise and technical support for regulatorytechnology innovationinitiatives.EssentialFunctions: Navigatethrough the Health authority (HA)...

**About this role**: Wells Fargo is seeking a Commercial Banking Portfolio Coordinator... **In this role, you will**: - Review credit information of loans for companies and industries - Analyze real estate related documents such as Lease Agreements and Appraisal - Respond to customer inquiries, generate status reports for management or bankers and contact...

**About this role**: Wells Fargo is seeking a Commercial Banking Portfolio Coordinator... **In this role, you will**: - Review credit information of loans for companies and industries - Respond to customer inquiries, generate status reports for management or bankers and contact available sources of information - Perform moderately complex credit...

**About this role**: Wells Fargo is seeking a Commercial Banking Portfolio Coordinator... **In this role, you will**: - Review credit information of loans for companies and industries - Respond to customer inquiries, generate status reports for management or bankers and contact available sources of information - Perform moderately complex credit...

**About this role**: Wells Fargo is seeking a Commercial Banking Portfolio Coordinator... **In this role, you will**: - Review credit information of loans for companies and industries - Review and analyze real estate documents such as Lease Agreements, and Appraisals - Respond to customer inquiries, generate status reports for management or bankers and...

**About this role**: Wells Fargo is seeking an Associate Due Diligence Coordinator. **In this role, you will**: - Conduct Know your Customer compliance process for Wholesale processes in line with the requirements of the United States of America Patriot Act as well as Wells Fargo corporate Anti-Money Laundering and Bank Secrecy Act policy requirements -...

Country: India Location: Building No: 12C, Floor 9,10,11, Building No: 12B -Stilt floor, Raheja Mindspace, Cyberabad, Madhapur, Hyderabad - 500081, Telangana, India Job Title – Test & Validation Preferred Location - Hyderabad, India Full time/Part Time - Full Time EXP – 6 Years - 11 Years Build a career with confidence! Carrier...