88 Fda Regulations Jobs

As a Senior Quality Auditor at Precision, you will play a crucial role in ensuring compliance with regulations and company procedures for clinical projects. Your responsibilities will include: - Supporting the Quality Management System by managing SOPs, training, and CAPA - Processing and maintaining documentation for controlled documents - Developing and administering training for employees and consultants - Hosting client/sponsor audits and supporting regulatory inspections - Coordinating and conducting assessments of vendors, including vendor audits - Conducting internal audits of quality systems, investigator site audits, and trial master file audits - Participating in computer systems v...

As a Clinical Project Manager at Clario's Medical Imaging team in Bengaluru, India, you will be part of a legacy with over 30 years of expertise in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. You will have the opportunity to contribute to ambitious goals and a clear vision for the future. **Role Overview:** You will be responsible for: - Identifying project guidelines and communication needs by reviewing study requirements and collaborating with key stakeholders - Defining project plans, establishing project reporting schedules, and providing project updates to relevant parties - Performing project analysis and management by identifying c...

As a Quality Control Specialist in a pharmaceutical company, your role is crucial in ensuring that all products meet quality standards and regulatory requirements before they are released to the market. You will be responsible for performing various testing and analysis procedures on raw materials, in-process materials, and finished products. Your collaboration with the production team will help in identifying and resolving quality issues and contributing to the continuous improvement of quality systems and processes. Key Responsibilities: - Conduct routine and non-routine testing of raw materials, in-process samples, and finished products using analytical techniques like HPLC, GC, and UV/VI...

Role Overview: As the Vice President of Supply Chain at Piramal Critical Care (PCC), you will be responsible for overseeing, leading, and developing the Global Supply Chain for PCC. Your role will involve managing External Supply Operations, end-to-end Global Planning, Logistics, Procurement, revenue forecasting, and Supply Chain Operations/Management in each of the three regions. You will report to the EVP of Global Operations and work closely with key stakeholders both internally and externally. Key Responsibilities: - Lead and oversee cost-efficient, sustainable supply chain operations in all three regions, including Planning, Sourcing, Order Fulfillment, Inventory Management, Logistics, ...

Role Overview: As an R&D Senior Executive in Cosmetics at Vimson Derma, your main responsibility is to formulate, develop, and enhance cosmetic products while ensuring compliance with industry regulations and market demands. Your role will involve conducting extensive research, innovating products, performing stability testing, and collaborating with various departments to introduce top-quality cosmetic formulations to the market. Key Responsibilities: - Develop and optimize innovative formulations for skincare, haircare, personal care, and cosmetic products based on market and client requirements. - Identify and evaluate new active ingredients, raw materials, and technologies to enhance pro...

As a Solution Architect for Intercompany Operations at Bristol Myers Squibb, you will play a crucial role in supporting the design and implementation of digital and process solutions for the seamless delivery of products on a global scale. Your responsibilities will include: - Supporting the advancement of digital and process solutions for drug delivery and Intercompany logistics. - Assisting in the development and design of SAP solutions for intercompany operations to ensure alignment with business objectives and technical requirements. - Analyzing current intercompany processes to identify opportunities for improvement, automation, and efficiency. - Providing SAP technical expertise, train...

We seek a highly motivated and detail-oriented Clinical Trial Associate (CTA) to join our clinical research team. The CTA will support the planning, execution, and management of clinical trials, ensuring compliance with regulatory guidelines and company protocols. This role requires strong organizational skills, excellent communication, and the ability to collaborate effectively with cross-functional teams. Key Responsibilities: Assist in the coordination and management of clinical trials from initiation to completion. Maintain and update trial documentation, including investigator brochures, protocols, and informed consent forms. Ensure compliance with Good Clinical Practice (GCP), regulato...

Define and implement reliability strategies and frameworks for software systems. Collaborate with cross-functional teams to integrate quality and reliability engineering throughout the SDLC. Lead risk management activities including DFMEA, hazard analysis, and traceability. Design and maintain post-market monitoring and alerting solutions to proactively address issues. Conduct root cause analysis and drive effective CAPA implementation. Develop tools and automation for reliability testing and validation. Ensure system availability through redundancy, failover, and recovery strategies. Support audits, regulatory inspections, and compliance with IEC 62304, ISO 13485, and ISO 14971. Mentor team...

As a Quality Control Chemist, your role involves ensuring that all products and raw materials tested meet the specified standards of excellence set for each product. This includes calibrating all instruments, testing and monitoring the stability of semi-finished goods, documenting and sampling raw materials, and performing daily testing activities to ensure availability of required materials at the store department. Your responsibilities also include documenting all inspections and tests for FDA compliance and ensuring that products meet the exact standards or minimum tolerance levels. Key Responsibilities: - Ensure that all products and raw materials tested meet specified standards - Calibr...

As an Associate II in Complex Gx, Regulatory Affairs at Teva Pharmaceuticals, you will be responsible for the preparation and submission of high-quality regulatory filings for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. Your role will involve managing regulatory submissions, collaborating with cross-functional teams, evaluating change controls, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. Additionally, you may serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives. Key Responsibilities: - Prepare, review, and compile new submis...

Role Overview: You are invited to apply for the position of Senior Validation Engineer at ValGenesis. In this role, you will play a crucial part in ensuring the compliance and quality of the innovative software solutions designed for the life sciences industry. Your responsibilities will include collaborating with various teams to develop validation strategies, creating and executing test cases, and upholding project quality standards. Key Responsibilities: - Work independently to deliver results - Collaborate with Product, Engineering, and Testing teams to understand Product functions - Review various Product Requirements such as Epics, User stories, User Requirements, Software Requirements...

Role Overview: As the ideal candidate for this role, you will be responsible for providing leadership in a technology-driven environment, specifically focusing on Manufacturing and Supply Chain applications. You will play a crucial part in the global ERP transformation initiative, aimed at enabling next-generation digital capabilities in pharmaceutical manufacturing. Your primary tasks will include leading the design, deployment, and validation of SAP S/4HANA solutions across core PTS areas such as Production Planning and Detailed Scheduling (PPDS), Quality Management (QM), and Master Data Management. It will be your responsibility to oversee and ensure the success of end-to-end solution del...

Role Overview: The ideal candidate for this role will have a proven track record of leadership and mentoring in a technology-driven environment, specifically within Manufacturing and Supply Chain applications. You will play a crucial role in the global ERP transformation initiative aimed at enabling next-generation digital capabilities in pharmaceutical manufacturing. Your responsibilities will include leading the design, deployment, and validation of SAP S/4HANA solutions across core PTS areas. Key Responsibilities: - Serve as the global functional lead for Plant-to-Stock processes in the ERP implementation program, driving solution design, data harmonization, and deployment across sites. -...

As a member of the RapidResponse product team, your role will involve conducting requirements gathering sessions with business stakeholders, scoping and evaluating business requirements, converting fits and gaps into tangible user requirements, and working with stakeholders on gating approvals. You will be responsible for defining acceptance criteria, identifying the right technology tools, and assisting in developing a robust solution within the product team. Your tasks will include managing solution delivery through various activities such as process design, data analytics, solution configuration, deployment, establishing performance metrics and new policies, testing, and knowledge managem...

Role Overview: You will be responsible for preparing consistent and high-quality technical documents related to Pharmaceutical Research and Development for Formulation at Teva. Your role will involve executing all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs, and SOPs. Maintaining open communication with R&D members to ensure timely delivery of high-quality documents independently with minimal supervision will be a key aspect of your responsibilities. Key Responsibilities: - Prepare documents and facilitate documentation management in R&D while ensuring correctness, completeness, and clarity following established guidelines. - Prepare documen...

In this role as a healthcare professional, your primary responsibility will be to provide patient care while ensuring compliance with standards. You will need to recognize and prioritize patient needs in alignment with physician instructions. Responsibilities: - Ensure quality care by adhering to physicians" standards - Educate patients on care procedures, whether in person or via phone - Maintain compliance with regulations such as OSHA, FDA, and HIPAA Qualifications: - Registered Professional Nurse with valid licensure - Certification in CPR, ACLS, and BCLS - Familiarity with OSHA, FDA, and HIPAA regulations - Ability to lift and position patients on endoscopy stretcher and provide transpo...

As a Clinical Research Physician (MBBS) at TruVita Wellness Inc., you will play a crucial role in clinically validating and enhancing the AI Doctor platform to ensure medical safety, ethical practices, and diagnostic accuracy. Your responsibilities will include: - Reviewing and validating AI-generated diagnostic outputs and treatment recommendations. - Supporting or leading clinical research studies to compare AI Doctor outcomes with human doctor diagnoses. - Designing study protocols, consent forms, and ethics committee submissions in collaboration with the Clinical Research Associate. - Supervising patient enrollment, data collection, and medical safety reporting in clinical validation tri...

As a Medical Writer II (Clinical Trial Transparency) at Syneos Health, you will play a crucial role in compiling, writing, and editing medical writing deliverables. Your responsibilities will include mentoring less experienced medical writers, developing various documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures with minimal supervision. - Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. - Collaborate with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deli...

As a Corporate Quality professional at Amneal, you will play a crucial role in bridging communication between departments, CMOs, and sites for writing, tracking, and reporting of events. Your primary responsibility will include ensuring timely submission of Field Alerts (FAR/BPDR) and Illegitimate Drug Notifications to FDA. You will act as an author, coordinator, and issuer as required, while also being responsible for identifying potential issues that may require reporting to FDA. Your role will involve assessing emerging trends and issues that could impact Amneal's compliance, customer experience, or reputation. You will provide support and leadership in determining and implementing CAPAs ...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

As a Senior Packaging Manager at The Ayurveda Experience, you will play a crucial role in developing innovative packaging solutions to enhance attractiveness, improve functionality, and reduce shipping and production costs. Your collaborative efforts with various departments will drive consumer-focused, innovative, and optimized packaging solutions. **Key Responsibilities:** - Coordinate with designers and content team members to achieve optimal design and packaging solutions. - Maintain records of packaging requirements and forecast future needs to prevent stock-outs or delayed deliveries. - Negotiate with vendors to secure the best rates without compromising on quality, and establish new v...

As a member of the team, you will play a crucial role in achieving exceptional business outcomes by effectively leading your team. Your responsibilities will include: - Utilizing your writing skills to craft narratives for adverse events and product complaints during intake, as well as developing customized responses for medical inquiries. - Handling customer requests through various channels such as phone, email, CRM, and chat platforms. - Identifying adverse events and product complaints during customer interactions, conducting intake procedures to generate compliant reports in accordance with EVERSANA-MICC and client SOPs. - Demonstrating knowledge of FDA post-marketing adverse event repo...

As a Principal Consultant for Manual Mobile, Regression, and Functional Testing at Genpact, you will play a crucial role in planning, executing, and reporting for testing of innovative software applications. Your collaboration with the Quality Management team, Technology Development, Business Operations, and external partners will ensure the optimal user experience and effective treatment to patients. - Perform manual execution of functional testing, regression testing, smoke testing, exploratory testing, and negative testing across various mobile devices in a dynamic environment. - Create test scripts, execute tests, and prepare reports and metrics for management and development partners. -...

Description: The Senior Consultant will be responsible for executing and overseeing pharma-focused mystery shopping programs, ensuring compliance with prescription drug regulations, patient privacy, fraud prevention, and payment card brand programs. The role requires 46 years of experience in pharmaceutical compliance, healthcare risk, or related industries. The Senior Consultant will also mentor Analysts and ensure accurate documentation of compliance risks. Key Responsibilities: Execute pharma-focused secret shopping programs across online pharmacies and healthcare platforms. Test prescription vs. OTC compliance, including controlled substances handling. Validate compliance with HIPAA, GDP...

The Senior Consultant will be responsible for executing and overseeing pharma-focused mystery shopping programs, ensuring compliance with prescription drug regulations, patient privacy, fraud prevention, and payment card brand programs (Visa VIRP, MasterCard BRAM, Amex/Discover HBR). The role requires 46 years of experience in pharmaceutical compliance, healthcare risk, or related industries. The Senior Consultant will also mentor Analysts and ensure accurate documentation of compliance risks. Key Responsibilities Execute pharma-focused secret shopping programs across online pharmacies and healthcare platforms. Test prescription vs. OTC compliance, including controlled substances handling. V...