10 Isi Toolbox Jobs

Regulatory Affairs Associate I Job Details | Teva Pharmaceuticals We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Accept All Cookies Find a Career With Purpose at Teva Search by Postal Code...

Key Responsibilities: Strong understanding of eCTD, NeeS, and ICH guidelines. Familiarity with Regulatory systems and Publishing tools. Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) Manage lifecycle submissions including variations, amendments, and renewals. Perform document-level publishing, hyperlinking, bookmarking, and validation. Conduct quality control checks to ensure submission readiness. Collaborate with cross-fun...

Develop and implement regulatory compliance programs to ensure adherence to industry standards.Conduct thorough analysis of regulatory requirements/ provide expert guidance on compliance matters.Collaborate with cross-functional teams to identify Required Candidate profile Strong knowledge of regulatory compliance principles, practices, and procedures.Excellent analytical, communication, and problem-solving skills.Ability to work effectively in a fast-paced environment

Develop and implement regulatory compliance programs to ensure adherence to industry standards.Conduct thorough analysis of regulatory requirements and provide expert guidance on compliance matters. Required Candidate profile Strong knowledge of regulatory compliance principles, practices, and procedures.Excellent analytical, communication, and problem-solving skills.Ability to work effectively in a fast-paced environment

Develop and implement regulatory compliance programs to ensure adherence to industry standards.Conduct thorough analysis of regulatory requirements and provide expert guidance on compliance matters. Required Candidate profile Strong knowledge of regulatory compliance principles, practices, and procedures. Ability to work effectively in a fast-paced environment with multiple priorities and deadlines.

Roles and Responsibility Develop and implement regulatory compliance programs to ensure adherence to industry standards. Conduct risk assessments and audits to identify areas for improvement. Collaborate with cross-functional teams to ensure seamless execution of regulatory requirements. Publish regulatory documents and reports as required by relevant authorities. Stay updated with changes in regulatory requirements and update internal processes accordingly. Ensure compliance with all applicable laws, regulations, and industry standards. Job Requirements Strong knowledge of regulatory compliance principles and practices. Excellent analytical, communication, and problem-solving skills. Abilit...

Roles and Responsibility Publish regulatory documents accurately and efficiently. Ensure compliance with regulatory requirements and guidelines. Collaborate with cross-functional teams to meet business objectives. Develop and implement effective publishing processes. Maintain high-quality standards in all published materials. Stay updated with changing regulations and industry trends. Job Requirements Strong knowledge of regulatory document preparation and submission. Excellent communication and collaboration skills. Ability to work in a fast-paced environment and meet deadlines. Strong attention to detail and quality control. Familiarity with industry-specific software and tools. Ability to...

Roles and Responsibility Develop and implement regulatory compliance programs to ensure adherence to industry standards. Conduct risk assessments and audits to identify areas for improvement. Collaborate with cross-functional teams to ensure seamless execution of regulatory requirements. Publish regulatory documents and reports as required by relevant authorities. Stay updated with changes in regulatory requirements and update internal processes accordingly. Ensure compliance with all applicable laws, regulations, and industry standards. Job Requirements Strong knowledge of regulatory compliance principles and practices. Excellent analytical, communication, and problem-solving skills. Abilit...

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a to Submissions Senior Publisher to join our A-team. The Submissions Senior Publisher are responsible for preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regulatory regi...