Regional Dossier Publisher, Sr Specialist

Job Description

The Regional Dossier Publisher (RDP) will work within the Company's Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations Department (RRO) supporting regional publishing activities for the LATAM region while also contributing to cross-regional publishing activities as needed.  The RDP is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by our decentralized publishing team who are working on dossiers for the region.  The RDP will have a good knowledge of the regulatory procedures and requirements in the region 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 submission needs to ensure they can meet their submission deadlines.  The RDP will also work with colleagues from the Head Quarters publishing functions to assist in the development, updates and implementation of the tools and procedures that support our submission planning and publishing procedures.

• The RDP will be responsible for identifying and maintaining requirements supporting regulatory dossier assembly (aka publishing) and delivery to regulatory health authorities or to the country organization in the region.
• The publisher will support the maintenance of related processes in accordance with regional/country requirements and will support the central publishing team responsible for executing the assembly processes to generate regional/country compliant to regulatory requirements.
• The publisher will execute the assembly and delivery processes, to meet critical submission targets. 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.
• He/she will play an advocating role for standardization across the supported countries within the region.
• Maintain the regional/country regulatory dossier assembly requirements (structure, organization, formats: paper and electronic, delivery methods, etc.)
• Lead technical impact assessments of regional/country requirements for regulatory submissions.
• Serve as the technical expert for local Country RA teams.
• Provide training to the Country RA teams on the publishing processes.
• Support the maintenance of processes and systems related to the assembly and delivery of regulatory submissions.
• Ensure readiness of the assembly and delivery related systems and toolsets for the region (publishing system, validation tools, media creation (e.g., CD, DVD). Participate in system testing, performance measures and other efforts necessary for readiness.
• Support the Central Publishing Team in understanding and applying the regional/local regulatory dossiers requirements.
• Develop and provide necessary training and communication related to publishing activities and/or processes.
• Execute the assembly and delivery process, when necessary, to meet submission targets.
• Serve as the technical expert and point of contact for health/regulatory authorities in the region, as required.
• Support the technical validation process. Support the region adopting global or established standards in the regulatory submissions area.

• Bachelor’s Degree in Life Sciences, Pharmacy, Engineering or IT with pharmaceutical industry experience.
• Advanced level in English (B2+ / C1).

• At least 4 years’ experience in the pharmaceutical industry including 2 years of regulatory operations or regulatory affairs area.

• Knowledge of Liquent Insight Publisher or 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.

• Excellent interpersonal skills and oral and written communication skills.

• Demonstrated ability to work under tight deadlines.

• Proven attention to detail and ability to work with a variety of technical applications.

• Strong knowledge of the English language. Working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project, Documentum, etc.) Knowledge of publishing requirements in the LATAM region. Knowledge of the regulatory registration procedures in the LATAM region will be considered as a plus.

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