933 Job openings found

Job Description:  Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions ...

  Job Description:  1. Preparing dossiers as per country specific guidelines 2. Countries knowledge- Africa, South East Asia works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees ...

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions ...

Position Overview: The Quality Assurance (QA) Head in the pharmaceutical industry plays a crucial role in ensuring that all aspects of the company's operations comply with regulatory requirements and quality standards. This leadership position involves overseeing the development, implementation, and maintenance of a robust quality management system to guarantee the ...

Job Description:           To assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials.  ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines ...

Job Profile for QA/RA :  2 -3 Years of Experience ? Experience to prepare and review the documentation required for the ISO 9001:2015,EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745,IMDR 2017.? Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s,Change Control, Deviation, CAPA, Incident, and ...

Duties and Responsibilities : Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted ...

  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...

Job Description   -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with ...