Senior Regulatory Publisher
An exciting opportunity has arisen for a Senior Regulatory Publisher at a leading biopharmaceutical organisation with extensive experience in discovering, developing, and manufacturing innovative human therapeutics. Based in the Netherlands, this opening is an exciting opportunity for applicants seeking to work with a truly global company with over 17,000 employees worldwide.
- Working as part of a global Regulatory Operations team, both leading and contributing to global filings Lead key submissions for EU, CAN, MENA and Emerging Markets Compilation.
- Publishing of submission dossiers for clinical trials, paediatrics and marketing applications.
- Working closely with submission content providers to advise on submission content, structure, planning and strategy.
- Working with publishing vendors Regulatory submission source document review, formatting, & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to the style guide and internal/external regulations.
- Preparing submission ready components from source documents according to regional regulatory agency guidance.
- Documenting management of ongoing submissions, e.g. building dossier structure, sourcing documents.
- Quality control of submission ready components and submission dossiers Preparation, dispatch and tracking of electronic and paper media.
- Maintaining submission information in Regulatory Registration Tracking system.
Skills and Requirements
- Bachelor's degree or equivalent combination of education and experience.
- Specialist knowledge of pharmaceutical/biotech industry gained in operationally focussed role.
- Demonstrate experience with Insight Publisher including associated publishing, validation, and review tools.
- Working with publishing vendors knowledge.
- Working in matrix environment.
- Dossier and Submission related Regulatory Guidance for EU, MENA and the Emerging Markets.
- Successful submission and maintenance of marketing applications in multiple regions.
- 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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