9 Dossiers Jobs

As a Regulatory Affairs Manager at Ferring India Laboratories, you will be responsible for the following key responsibilities: - Prepare, compile, and submit regulatory dossiers and submission data. - Manage Test and Manufacturing License applications with state and central drug authorities. - Handle regulatory submissions, variation filings, technical report writing, and query responses. - Ensure compliance with Drugs & Cosmetics Act, New Drug & Clinical Trial (CT) Rules, and GMP guidelines. - Ensure adherence to national and international regulatory requirements. - Review product labeling and artworks for regulatory compliance. - Liaise with state and central regulatory bodies (e.g., CDSCO...

As a BI developer, your main role will be to develop, deploy, and maintain BI tools and interfaces. This includes query tools, data visualization and interactive dashboards, ad hoc reporting, and data modeling tools. **Key Responsibilities:** - Design and develop advanced reports and state-of-the-art dashboards using MicroStrategy Developer/ Web. - Create and use Dossiers in Microstrategy. - Experience in Performance Tuning and Optimization using VLDB and database query tuning techniques. - Write SQL queries. - Design, develop, and test reporting solutions & dashboards with MicroStrategy Components. - Interact with business points of contact, ETL, and data architect teams to build models sui...

As a candidate for this role, you should have 5+ years of relevant experience in Microstrategy and have worked on development projects. You should be proficient in MicroStrategy Schema design and have experience in developing Schema and Public Objects in MicroStrategy. Additionally, you should be skilled in developing Intelligent Cubes, Dashboards, and Dossiers in MicroStrategy. Your responsibilities will include creating application dashboards, performing automated compliance audits, participating in solution architecture, proof of concepts, and estimations. It is essential that you have experience with MicroStrategy Object Manager. Qualifications Required: - 5+ years of experience in Micro...

As an experienced MicroStrategy (MSTR) Consultant with 8+ years of expertise, your role will involve supporting offshore operations by utilizing your deep knowledge of metadata, data modeling, dashboard development, and performance optimization. Your troubleshooting skills and ability to collaborate with business users to address technical queries will be crucial in this role. - Develop, configure, and maintain MicroStrategy solutions based on business needs. - Understand and manage metadata efficiently to configure data models effectively. - Work with star schemas, slowly changing dimensions (SCDs), and hierarchical models to optimize reporting. - Design interactive dashboards tailored to d...

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

Role & responsibilities Job description Ensure that a company's products comply with the regulations of the regions. Keep up to date with national and international legislation, guidelines and customer practices Respond to queries from Centre for Veterinary Medicines (CVM). Collect, collate and evaluate scientific data from FR&D, AR&D and DQA. Develop and write clear arguments and explanations for new product licences and licence renewals at R&D site. Prepare submissions of licence variations and renewals to strict deadlines as per CVM. Monitor and set timelines for licence variations and renewal approvals Advise scientists (AR&D, FR&D, Pkg.-R&D) on regulatory requirements. Provide strategic...

You have hands-on experience working with the US, Canada, and European Market regions in regulatory publishing and submissions. Your expertise includes managing dossiers, using Lorenz, and working with Docubridge. As a Submission Publisher, you will be responsible for regulatory submissions related to the pharmaceutical industry. This is a full-time, permanent role in the ITES/BPO/KPO sector, specifically within the functional area of pharmaceuticals. You should be well-versed in handling dossiers, using Lorenz software, and working with Docubridge. The job code for this position is GO/JC/20989/2025. Your recruiter for this role is HariharanA.,

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines receive...

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6...