169 Ich Guidelines Jobs - Page 3

At Allucent, you will be a Sr. Clinical Research Associate Contractor (Sr.CRA) responsible for independently controlling and monitoring investigational sites, ensuring clinical studies are conducted according to trial protocols and in compliance with SOPs, regulations, and Good Clinical Practice principles. **Key Responsibilities:** - Govern highest quality standards for trial monitoring activities. - Conduct all study tasks in compliance with quality standards while maintaining efficiency. - Monitor activities at clinical study sites to ensure adherence to protocols, ICH, GCP, SOPs, and regulations. - Prepare and submit quality Site Visits Reports and Contact reports. - Maintain and update ...

As a Quality Review Specialist at Fortrea, your role involves ensuring the delivery of high-quality service to both internal and external clients in a safe and cost-effective manner. You will be responsible for complying with various legal requirements related to health and safety regulations. Key Responsibilities: - Perform quality review of assigned cases and compile quality metrics to identify trends. - Address periodic client quality reviews and assist in preparing corrective and preventive actions. - Ensure implementation of Corrective and Preventive Action (CAPA) results in coordination with project managers. - Review various cases and safety reports for global regulatory submissions. ...

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...

Role Overview: As a Manager- Regulatory Affairs-International, your primary purpose will be to manage and oversee the preparation, review, and timely submission of regulatory dossiers in CTD and ACTD formats for international markets. You will ensure ongoing regulatory compliance and support product lifecycle management across ROW and emerging markets. Key Responsibilities: - Prepare and review Common Technical Document (CTD) and ASEAN Common Technical Document (ACTD) dossiers. - Coordinate with manufacturing sites and R&D to gather necessary data and documents for regulatory submissions. - Ensure plant compliance with regulatory requirements and facilitate timely implementation of changes. ...

As a highly skilled Formulation R&D professional, you will be leading the development of oral drug delivery systems, with a primary focus on soft gelatin capsules, tablets, and sachets. Your role will encompass driving end-to-end formulation development, process optimization, and technology transfer from lab to commercial scale. You will be responsible for conceptualizing and executing formulation strategies, troubleshooting technical issues, and ensuring successful product development in alignment with regulatory and GMP standards. Your collaboration with cross-functional teams including analytical R&D, manufacturing, and regulatory affairs will be crucial for innovation and continuous impr...

Description Sr Safety Specialist (Literature Review) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate proble...

Description Safety & PV Specialist II (Literature Review) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate p...

As a Clinical Research Associate II at Syneos Health in Shanghai, your role will involve performing a variety of site management activities to ensure regulatory compliance and protocol adherence. You will be responsible for conducting site qualification, initiation, monitoring, and close-out visits, both on-site and remotely. Your key responsibilities will include: - Evaluating site performance and providing recommendations for site-specific actions - Ensuring informed consent procedures are properly documented for each subject/patient - Assessing factors that may impact subject/patient safety and clinical data integrity - Conducting source document reviews and verifying clinical data accura...

Role Overview: Preparation, review, and submission of responses to deficiency letters raised by the UK/EU regulatory agencies during the evaluation of Marketing Authorisation Applications (MAAs). The role ensures high-quality and compliant responses in line with regulatory expectations and timelines. Key Responsibilities: Coordinate with cross-functional teams (Development, Clinical, Nonclinical, Pharmacovigilance, Quality, Manufacturing, etc.) to obtain required information and justifications. Consolidate and review all data and documents to ensure consistency, accuracy, and regulatory compliance prior to submission. Draft and review responses addressing concerns on quality, safety, and eff...

Documentation & SOP Management Prepare and implement standard operating procedures, batch manufacturing records, protocols, cleaning procedures, and log sheets. Maintain all documentation in compliance with cGMP and regulatory requirements. Ensure timely review and revision of SOPs related to FP departments. Quality & Compliance Activities Handle QMS activities including change controls, deviations, incidents, and risk assessments. Perform DQ, IQ, OQ, and PQ qualifications for equipment. Support in audit preparedness and ensure all documentation is audit-ready. Training & Team Management Ensure departmental employees are trained as per the TRIMS training schedule. Attend and ensure participa...

Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines. Assess the regulat...

As a Senior Regulatory Associate (CMC) at Syneos Health, you will play a crucial role in ensuring compliance with regulatory guidelines and requirements. Your responsibilities will include: - Having a practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks such as FDA and EMA. - Mandatory post-approval variation experience for the EU market and preferred pre-approval MAA dossier experience for ROW. - Strong expertise in preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, renewals, annual reports, and RTQs. - Supporting change control assessment and impact assessments for global markets. - Executing day-to-day tasks...

Role Overview: You will be responsible for managing a team of regulatory specialists and ensuring timely regulatory submissions to support study start up. As a Manager at Velocity Clinical Research, you will proactively address challenges, drive efficiency, and provide guidance on regulatory compliance. Key Responsibilities: - Manage a team of regulatory specialists to ensure timely and efficient regulatory submissions. - Prepare study-specific documents such as protocols, informed consent forms, and HIPAA authorizations for review by the IRB. - Submit and manage amendments, adverse event reports, and other IRB-required submissions. - Provide guidance on conflict of interest paperwork and ma...

As a remote analytical support personnel at PPL sites, your role involves reviewing analytical data and preparing various documents such as specifications, test methods, and protocols. You will be responsible for uploading documents for review in ENSURE and initiating QMS elements in TrackWise/eDMS. Additionally, you will prepare and review stability protocols and reports, and conduct stability data trending and analysis. Key Responsibilities: - Review analytical data generated in the analytical lab (QC/AS) including Cleaning verification data, IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data in accordance with cGMP...

As an eClinical Systems Analyst, your role involves having a good understanding of clinical trial processes and related systems, particularly focusing on the Trial Master File (TMF) processes. You will work closely with Study Owners to ensure that the TMF is complete, contemporaneous, and accurate across all clinical trials and programs conducted by our clients. Your responsibilities will include assisting clients in the development, maintenance, and closeout of clinical trials using various eClinical systems such as eTMF, Study Start up (SSU), and Clinical Trial Management System (CTMS). Your key responsibilities in this role will include: - Collaborating with Study Owners on start-up, main...

Role Overview: You are sought after to join the Research and Development team at Dr. Reddys Laboratories Ltd. as an Analytical Scientist for the Injectable Division. Your role will involve developing and validating analytical methods for injectable products, ensuring compliance with regulatory requirements, conducting literature reviews, scaling up for manufacturing batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. It is essential to have a strong understanding of analytical principles, excellent documentation skills, and the ability to work effectively in a collaborative team environment. Key Responsibilities: - Develop...

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...

As a Safety Specialist II at our company, your role will involve the following responsibilities: - Authoring and reviewing various Aggregate Safety Reports such as DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports as required by the project. - Reviewing aggregate safety data, generating line listings (LL) and summary tabulations (ST), and incorporating them into the appropriate templates. - Analyzing safety and regulatory data provided by clients to prepare comprehensive Aggregate Reports. - Conducting literature screening to include significant safety articles in the respective sections of aggregate reports. - Compiling benefit-risk evaluation sections provided by medical reviewe...

As a QA/QC Manager at our company, you will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your role will involve the following key responsibilities: - Preparation, review, and implementation of SOPs and STPs. - Checking of all QC related records like analytical reports and logbooks. - Planning and distribution of samples for analysis of Raw Materials, Intermediates, and finished products. - Designing and conducting Stability studies as per ICH Guidelines. - Developing and validating analytical testing methodology used to control raw materials, production intermediates, and final products. - Preparation and ma...

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...

As an Executive/ Sr. Executive in Quality Management System (Analytical Assurance), your role will involve leading the Out of Specification investigations and managing core QMS activities related to QC. Your responsibilities will include: - Triggering out of specification investigations when test results fall outside predefined specifications. You will be required to design and conduct tests to confirm or eliminate suspected root causes. - Handling QMS documents such as Incidents & Deviations. - Evaluating change control & CAPA processes. - Reviewing analytical documents like worksheets, specifications, methods of analysis, stability protocols & summary reports, and logbooks from the Quality...

Job Title: Clinical Quality Compliance Manager Location: Bengaluru, Karnataka, India Reports To: QA/Compliance Director or Clinical Operations Director Job Summary: Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites. You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory requirements. Key Responsibilities: Conduct audits of clinical research sites across phases IIV. Review CRFs, informed consent forms, and regulatory documents. Identify and report audit findings; recommend corrective actions. Support site staff with compliance guidance and training. Prepare audit reports and follow up on CAPA implementation. ...

As a Safety Specialist I at Precision, you will play a crucial role in the safety team by handling all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and post-marketing safety programs. Your responsibilities will include: - Processing ICSRs following Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triage and evaluation of ICSR data for completeness, accuracy, and regulatory report ability - Entering data into the Argus Safety Database - Coding events, medical history, concomitant medications, and tests - Drafting case narratives - Assessing information for queries and ensuring satisfactory re...

About Us Friday Plansis a technology-driven US-based company evolving from a leading online pharmacy into a vertically integrated pharmaceutical company. Our mission is to develop, manufacture, and commercialize our own portfolio of medicines for the US market. We are seeking a seasoned regulatory leader to navigate this journey and build our regulatory function from the ground up. Position Summary We are looking for a strategic and hands-on Director of Regulatory Affairs to lead all regulatory activities for our product portfolio targeting the US market. This individual will be responsible for developing and executing the regulatory strategy for our pipeline, from early development through ...

Job Overview:Manages the document classification under Smart Inbox and ARC review (as applicable) as well as document deletion. Summary of Responsibilities: Maintains an understanding of applicable regulatory requirements. Managing electronic Trial Master Files (eTMF), (Trial, Country, and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study Team Member - Responsible for document classification under Smart Inbox (when applicable), ARC review, document deletion. TMF Classifiers or Start Up team members as part of the SSU Vault Model typically fulfil this role (TMF Classifier). Maintains the TMF in a state of audit readiness ...