Job description we are currently seeking a trainee regulatory associate to join our growing team in colombia. within the role, you will: - manage end-to-end publishing support for initial ind/nda/maa applications and life cycle maintenance of all applications across the globe - collaborate with various departments for planning, preparation, publishing, and quality control checks of submissions - support the development of submission-ready documents for electronic submissions including formatting, hyperlinking and processing ms word and adobe acrobat documents - develop and maintain up-to-date knowledge of established agency standards and procedures for regulatory submissions - support ectd, nees/esub, and paper submissions format for global agencies - troubleshoot document issues with adobe acrobat and ms word and identify gaps in the submission and address with the respective client stakeholders - manage technical aspects for assigned submissions and status updates - perform quality checks on the published outputs, ensure no unacceptable warnings and validation errors before the submission is filed with the relevant ha - perform on the job training to follow train the trainer model for beginners/fellow colleagues and provide qc feedback for continuous improvements - review and interpret the data to establish the system/tools required to be populated in line with current standard operating procedures and/or business process documentation to support centralized data management team (if necessary) - perform data entry and quality control tasks associated with regulatory s...
Job description we are looking for a junior regulatory associate to join our expanding team. the successful candidate will: - be responsible for the review and finalization of global regulatory strategy documents, ctd sections for ind, cta, bla, nda, and anda submissions to ensure effective data presentation as per guidance - be responsible for effective co-ordination with cross functional teams, site, and global regulatory affairs teams for the authoring, review, and finalization of dossiers for the pipeline products to ensure effective data presentation and quality - prepare quality dossiers for pipeline molecules and supplements to support product launch. - monitor and set timelines for filing ma transfers, variations, license renewals, product amendments/supplements, and other product life cycle management activities including annual reports and safety report filing, etc. - collaborate with both global and other regional regulatory client teams to author quality regulatory submissions for pipeline products - review health authority queries and co-ordinate global strategy for response - provide adequate support, including responding to deficiency letters, to both global and other regional regulatory client teams for securing timely approval of regulatory submissions - provide regulatory support to team, participate, and provide regulatory advice in technical review. - identify and assess regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate any risks - drive resolution of issues. communicate issues, impact, and out...
Job description we are currently seeking a regulatory associate to join our growing team in colombia. within the role, you will: - review and interpret data to establish the system/tools required to be populated in line with client sops and/or business process documentation - perform data entry and quality control tasks associated with regulatory systems - review audit reports and resolve errors to ensure the integrity of data - identify issues and provide input into solutions - perform retrospective remediation tasks - adhere to quality control procedures and standards related to the systems or tools to ensure regulatory compliance - support global/local team members with data management workload when necessary to provide flexible support for the portfolio. - adhere to compliance standards - act as regulatory data sme in regions supported - produce country/regional reports as required - support audit(s) as part of regulatory data/system scope desirable skills and experience - minimum of 1 – 2 years of pharmaceutical experience is required - experience of working in a highly regulated environment - able to effectively communicate using the english language – intermediate to advanced in both written and spoken - regulatory strategy experience - ability to work with autonomy and as part of a team in a busy environment - good accuracy and attention to detail - problem-solving ability - project management and coordination skills - proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards - a quick learner who is self-...
Cree una alerta de empleo y reciba nuevas ofertas que se adaptan a su perfil desde más de 2550 sitios web de empleo