Regulatory Affairs - Regional Dossier Publisher

Praha
Trvalý pracovní poměr
Plný úvazek

Před 23 dny

Job DescriptionThe Regional Dossier Publisher (RDP) will work within the Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the EU+EEMEA Regulatory Operations (RRO-EU+EEMEA) Team.The RDP is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by our regional publishing team who are working on dossiers for the regions. The RDP will have a good knowledge of the regulatory procedures and dossier requirements in the regions and be able to apply this to the publishing processes and tools to ensure that the submissions delivered to the Country RA groups meet their specific needs.The RDP will also be involved with supporting Country RA teams with their local publishing and submission transmission needs and ensure they can meet their submission deadlines. The role will assist HQ Colleagues within RPP in the development of the tools and procedures that support our submission publishing proceduresPrimary Activities include but are not limited to:The RDP will be the regional expert for regulatory submission capabilities, including dossier structures and file formats, electronic submissions, and transmission (e.g., agency gateways), dossier repositories and databases.The RDP will be responsible for identifying and maintaining dossier format requirements supporting regulatory dossier assembly (aka publishing) and delivery to regulatory health authorities or to the country organization in the region.The RDP will support the maintenance of related processes in accordance with regional/country requirements and will support the central publishing team responsible for the execution of the assembly processes.The RDP will play an advocating role for standardization across the supported countries within the region.The RDP will lead technical impact assessments of regional/country requirements for regulatory submissions and serve as the technical expert for local Country RA teams and providing training to the Country RA teams on the publishing processes.The RDP will serve as the technical expert and point of contact for health/regulatory authorities in the regionThe RDP will support the maintenance of processes and systems related to the assembly and delivery of regulatory submissions.The RDP will also perform publishing in executing the assembly and delivery processes to meet critical submission targets.The RDP will participate to “Improvement process and tools project” by taking part of system testing, performance measures and other efforts necessary for readiness.The RDP will support the technical validation process.The RDP will play a role as Mentor/Coach/Manage external sources publishers.Profile:Minimum 3 years publishing experienceKnowledge in Ennov Insight Publisher and/or Lorenz Docubridge, knowledge of other publishing tools will be considered as a plus.Strong analytical and customer service skills with the ability to work with varying grade levels, educational background, and departments.Demonstrated ability to work under tight deadlines.Proven attention to detail and ability to work with a variety of technical applications.Working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project) and Document Management systems.Knowledge of publishing requirements in the EU and EEMEA regions.Knowledge of the regulatory registration procedures in the EU and EEMEA regions will be considered as a plus.What we offer:

Exciting work in a great team, global projects, international environment
Opportunity to learn and grow professionally within the company globally
Hybrid working model, flexible role pattern
Pension and health insurance contributions
Internal reward system plus referral program
5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution
Cafeteria for tax free benefits according to your choice (meal vouchers, Lítačka, sport, culture, health, travel, etc.), Multisport Card
Vodafone, Raiffeisen Bank, Foodora, and other discount programs
Up-to-date laptop and iPhone
Parking in the garage for drivers or showers for bikers
Competitive salary, incentive pay, and many more

Required Skills: Adaptability, Adaptability, Adobe Acrobat, Assembly Processes, Audits Compliance, Communication, Customer Service, Detail-Oriented, Document Management, Drug Regulatory Affairs, Electronic Document Management System (EDMS), Employee Training Programs, Global Communications, Improvement Projects, International Standardization, Maintenance Management, Management Process, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Process Management, Project Management, Publishing, Publishing Process, Regulatory Affairs Management {+ 5 more}Preferred Skills:Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 04/12/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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