88 Fda Regulations Jobs - Page 3

As an AI Engineer at ManMukt, a pioneering organization dedicated to transforming mental healthcare through innovative AI solutions, you will play a crucial role in developing and implementing AI models specific to mental health applications. Your expertise will contribute to creating accessible, personalized, and effective digital health tools that aim to make quality mental healthcare available to everyone, everywhere. Your responsibilities will include designing, developing, and deploying sophisticated machine learning and deep learning models tailored for mental health, as well as leading the development of natural language processing systems to understand emotional and psychological con...

The Senior Regulatory Administrator (SRA) role is crucial in providing vital administration and operational support to the Regulatory Affairs department. As an SRA, your primary responsibility is to ensure the efficient management and upkeep of regulatory documents within the regulatory systems. Your pivotal role involves overseeing the accuracy, compliance, and timely submission of regulatory documentation to regulatory bodies such as the FDA, EMA, and other international authorities. Your duties will include managing the organization of regulatory documents for submissions, ensuring adherence to relevant guidelines and regulations, optimizing processes, mentoring team members, and fosterin...

As a Clinical Research Associate, your responsibilities will include developing and reviewing study protocols and informed consent documents, monitoring clinical trial progress to ensure adherence to GCP, FDA, and IRB regulations, collecting, managing, and analyzing clinical data, preparing regulatory submissions and study reports, and collaborating with cross-functional teams including investigators and coordinators. This is a full-time position suitable for freshers. The benefits include health insurance. The work schedule is during the day shift and the work location is in person.,

As a Labeling Specialist in the Pharmaceutical Industry, you will be responsible for developing US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s. Your role will involve ensuring that labeling meets all legal and regulatory requirements through QC, proofing, editing, and formatting of documents. You will coordinate the review and approval of final submission documents with all relevant departments. Your expertise will be crucial in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities. Serving as a Subject Matter Expert (SME) in SPL/drug listing, you will provide gu...

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback...

This role as a Clinical Research HRPP Program Specialist involves serving as a lead for monitoring regulations and guidance to ensure the implementation of changes to operational processes or best practices for clinical research. You will provide expert advice to principal investigators (PIs), Clinical Research Coordinators, leadership, and other ORSP personnel involved in ensuring compliance throughout the lifecycle of clinical research and trials. Responsibilities include ongoing education and training of clinical research personnel, as well as on-site clinical research monitoring of industry-funded and investigator-initiated clinical research studies within the institution. Quality manage...

The Senior Quality Auditor provides support to the audit program and clinical projects to ensure compliance with regulations and Precision procedures. You will be responsible for offering oversight and subject matter expertise to quality and compliance activities, aiding project teams throughout all phases of a clinical study. Your essential job functions will include supporting the Quality Management System by managing SOPs, training, and CAPA. You will be required to process and maintain documentation for controlled documents as needed. Additionally, you will develop and conduct training for employees and consultants. Hosting client/sponsor audits, supporting regulatory inspections, coordi...

Are you seeking a rewarding career in Project Management within the Clinical Research industry Join Clario's Medical Imaging team in Bengaluru, India, and become a part of a legacy with over 30 years of expertise. Clario specializes in offering seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have set ambitious goals and have a clear vision for the future. This is your opportunity to be a part of our journey as a Clinical Project Manager. What we offer: - Competitive compensation - Attractive benefits including security, flexibility, support, and well-being - Engaging employee programs - Technology for hybrid working and great onsite facil...

The Quality Control Specialist in our pharmaceutical company located in Thanjavur plays a crucial role in ensuring that all products adhere to quality standards and regulatory requirements before being released to the market. You will be responsible for conducting a variety of testing and analysis procedures on raw materials, in-process materials, and finished products. Your collaboration with the production team to identify and resolve quality issues will contribute to the continuous improvement of our quality systems and processes. Your key responsibilities will include performing routine and non-routine testing using various analytical techniques like HPLC, GC, and UV/VIS spectroscopy. Ad...

You are a passionate, dedicated, and detail-oriented professional, and an exciting opportunity awaits you to join the Quality Assurance Team at Zydus Takeda Healthcare Private Limited in Turbhe, Navi Mumbai. This joint venture between Zydus Lifesciences and Takeda Pharmaceuticals is committed to maintaining the highest level of quality and safety in its products. As a Senior Executive / Executive in Quality Assurance, based in Navi Mumbai, you will play a crucial role in In-Process Quality Assurance (IPQA). Your responsibilities will include monitoring and controlling the quality of products during the production process to ensure compliance with regulatory standards and company quality poli...

Job Description: Support daily DSCSA operations including product serialization, traceability, and exception handling. Coordinate with internal teams (QA, IT, Logistics) and external partners (CMOs, 3PLs, wholesalers) to ensure accurate product data exchange. Monitor and investigate DSCSA compliance issues such as "data no product" and "product no data" exceptions. Ensure accurate and timely submission of T3 data (Transaction Information, Transaction History, and Transaction Statement). Reconcile all outbound shipments from the 3PL using the middleware system to ensure compliance with DSCSA guidelines. Maintain records of DSCSA-related activities in compliance with FDA regulations. Assist wi...

You will be joining Vimson Derma, a renowned contract manufacturer of cosmetic and medicated products located in Ahmedabad with over 45 years of experience in the cosmetics and dermatology industry. As a trusted name in the field, Vimson Derma holds certifications such as GMP, GLP, and ISO 9001:2015, ensuring the highest quality standards. The company's product range includes dusting powders, talcum powders, shampoo, conditioner, cream, gel, lotions, oil, soaps, sunscreen, serums, and more. With a substantial client base of over 200 companies across India, Vimson Derma is committed to delivering excellence in the products they manufacture. As the R&D Senior Executive in Cosmetics, your prima...

Job Description: To apply to a Varex Imaging position, please create an account and sign-in. CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account. Varex Imaging is hiring a System Software Engineer in Test in the fast-growing X-Ray Imaging Components division. The Software Engineer in Test will bring real-world experience to our team by helping to develop automated integration and robustness testing to ensure system software performs as designed. We are looking for candidates that will thrive in a fast-paced, self-directed environment and can hit the ground running in a critical division of our company. There will be opportunities to work both individua...

The VP of Supply Chain at Piramal Critical Care (PCC) plays a pivotal role in overseeing and developing the Global Supply Chain operations under the strategic direction of the Executive Committee (Excom) and the EVP of Global Operations. In this position, you will be responsible for managing External Supply Operations, end-to-end Global Planning, Logistics, Procurement, revenue forecasting, and Supply Chain Operations across the three regions where PCC operates. As the VP of Supply Chain, you will collaborate with key stakeholders both internally and externally. Internal stakeholders include Regional Supply Chain heads, Excom Vice Presidents, Sales General Managers, and Alliance Management H...

As a Maintenance Engineer at our Pharmaceutical Company in Nagpur, Maharashtra, your primary responsibility will be to ensure the reliable operation, maintenance, and repair of mechanical systems and equipment in our manufacturing facility. In this role, you will play a crucial part in performing preventive and corrective maintenance, troubleshooting equipment issues, and ensuring compliance with regulatory standards to uphold production efficiency and safety. Your key responsibilities will include conducting routine preventive maintenance, inspections, and repairs on a variety of mechanical systems such as HVAC, pumps, compressors, and conveyors. You will also be expected to diagnose mechan...

The increasing demand for observational research (now commonly referred to as real-world evidence [RWE]) from regulatory and reimbursement authorities has made observational research a crucial component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with industry-leading analytical capabilities that generate RWE to support business needs across a product's lifecycle. CfOR scientists collaborate with internal stakeholders and industry experts to design, conduct, interpret, and publish observational research that informs decision-making at various stages from molecule development to clinical trial design and the safety and e...

This role requires you to be highly skilled in technology transfer of Injectable products to manufacturing plants, including scale-up activities and demonstrating technical capabilities. You will play a key role in ensuring accessibility to both current portfolio and pipeline products. Additionally, you will share responsibility for achieving targeted product execution goals within the department/organization. Your duties will involve documentation, evaluation, and monitoring of batches at the manufacturing site. Your responsibilities will include performing product transfer activities for sterile products as assigned by the Manager/Senior Manager/Designee. You will be involved in the execut...

As a Senior Medical Writer at Syneos Health, you play a vital role in leading the clear and accurate completion of medical writing deliverables. Your responsibilities include managing medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. You will be responsible for completing various documents such as clinical study protocols, reports, patient narratives, annual reports, and more. Adhering to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, and client standards, is essential. Your role involves coordinating quality and editorial reviews, ensuring...

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As the Head of Quality and Regulatory Compliance at the India Innovation Center (IIC) in Bangalore, India, you will play a crucial role in leading the Quality and Compliance Groups within the organization. Reporting to the Supervisor Director Quality and Compliance Critical Care, you will be an integral part of the leadership team at Getinge India. Your primary responsibility will be to ensure the effective establishment and maintenance of quality systems in the projects executed at IIC. You will be tasked with providing strategic leadership and management for the Quality Systems at the IIC, developing a competent and accountable Quality organization aligned with business objectives and comp...

You have an opportunity as a Warehouse and Logistics Manager where you will be responsible for overseeing warehouse operations, inventory control, team management, safety compliance, and logistics and supply chain management in the pharmaceutical/API sector. Your key responsibilities include managing warehouse operations such as receipt, storage, and dispatch of materials, optimizing warehouse layout for efficiency, implementing inventory tracking systems, maintaining accurate inventory records, ensuring compliance with regulatory standards, and supervising warehouse staff. You will also be involved in coordinating with QA/QC for proper material handling, conducting training programs on safe...

As an employee at Advarra, you will be part of a passionate team dedicated to making a difference in the world of clinical research and advancing human health. With our rich history in ethical review services and innovative technology solutions, we are leading the industry in breaking down barriers and accelerating trials. Your role will be crucial in developing and maintaining internal budgets for clinical trial sites, negotiating budgets with sponsors and CROs, and ensuring compliance with regulations and industry best practices. You will play a key role in the development and approval of internal budgets, redlining budgets based on coverage analyses for new studies, and capturing all nece...

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the product lifecycle through obsolescence. Your responsibilities will include assessing changes made to the device post-launch to determine the regulatory impact of these changes on current clearance. You will ensure regulatory compliance by conducting thorough assessments and submitting the necessary documentation for product clearances and approvals from regulatory bodies such as the FDA and Notified Bodies. In this role, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based on regulatory changes. You wil...

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagno...

You are seeking a Lead Engineer - System Verification to join our team. In this role, you will be responsible for executing verification tests, developing test methods, analyzing measurement data, and reporting test results in compliance with international standards. Your tasks and responsibilities will include translating requirements into verification plans and protocols with a focus on traceability. You will develop reproducible and maintainable verification test methods, test set-ups, and tools. It will be your responsibility to define and document the impact on system-level behavior resulting from design changes and ensure thorough verification. You will create, implement, and enhance p...