Regulatory Documentation and Submissions Publisher
A leading Pharmaceuticals company is currently recruiting for a Regulatory Documentation and Submissions Publisher based at their office in Switzerland. The vacancy offers an exciting opportunity to work with a company with over 1,500 professionals and is a leader in the field of pulmonary arterial hypertension (PAH).
- Providing electronic publishing support for document submissions to competent authorities.
- Providing support to the Document Specialist, Regulatory Affairs/Regulatory Submissions Specialist by uploading documents to iTRACK.
- Providing format QC, reformatting to standards as required, and electronic approval as required, thus ensuring compliance of electronics documents with eCTD standards and requirements.
- Responsible for eCTD submission compilation: assigning metadata, locations within the eCTD modular structure (with guidance from authors where necessary), building XML backbone, eCTD leaf titles and lifecycle operators.
- Ensuring that submissions are compliant with national health authority requirements
- Responsible for quality control (QC) of the submission, its contents and backbone, both manually and through appropriate validation software applications.
- Managing the submission of eCTD dossiers through the EMA Submissions Gateway and other portals.
- Acting as the Data Entry Responsible for the Regulatory Management System (RMS) in line with the relevant quality system documents.
- Contributing to the overall planning and tracking of regulatory activities, including quality control (QC) and maintenance of existing data.
- Participating in projects related to the work of Regulatory Operations.
Skills and Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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