Regulatory Affairs - Regional Dossier Publisher

Job Description

As a Regional Dossier Publisher, you will:

• Serve as the regional subject matter expert for regulatory submission publishing, including dossier structures, file formats, electronic submissions, transmission gateways, and dossier repositories.
• Identify, maintain, and apply dossier format requirements to support the assembly and delivery of regulatory submissions to health authorities and country organizations.
• Support country Regulatory Affairs teams with local publishing and submission transmission needs to help ensure critical deadlines are met.
• Collaborate with central publishing teams to maintain and execute publishing processes in line with regional and country requirements.
• Promote standardization across supported countries and encourage consistent publishing practices.
• Lead technical impact assessments for regional and country regulatory submission requirements.
• Provide technical guidance and training to country Regulatory Affairs teams on publishing processes and tools.
• Act as a technical point of contact for health and regulatory authorities in the region.
• Support the maintenance and validation of processes and systems related to regulatory submission assembly and delivery.
• Perform publishing activities to meet key submission timelines.
• Participate in improvement projects, including system testing, readiness activities, and performance measurement initiatives.
• Support technical validation efforts.
• Mentor, coach, and manage external publishing resources as needed.

Required Experience and Skills

Experience:

• Minimum 4 years of publishing experience in regulatory submissions.
• Hands-on experience with Ennov Insight Publisher and/or Lorenz Docubridge.
• Experience supporting EU and EEMEA publishing requirements is required.
• Knowledge of regulatory registration procedures in the EU and EEMEA is considered a plus.

Technical Skills:

• MS Office applications
• Adobe Acrobat
• MS Project
• Document Management Systems
• Proven ability to work with a variety of technical applications and publishing systems.
• Familiarity with dossier assembly, electronic submission formats, and submission transmission tools.

Core Competencies:

• Strong analytical skills and attention to detail.
• Excellent customer service and communication skills.
• Ability to work effectively with stakeholders at different levels and across departments.
• Proven ability to work under pressure and meet tight deadlines.
• Strong organizational skills and a proactive, solution-oriented mindset.

What We Offer:

• A dynamic role within a highly collaborative regulatory operations environment.
• The opportunity to work on important regional submission activities across EU+EEMEA.
• Exposure to a broad range of regulatory publishing processes, systems, and improvement initiatives.
• The chance to contribute to standardization, technical readiness, and continuous improvement efforts.
• Opportunities to support, train, and mentor colleagues and external resources.
• A role with meaningful impact on the timely delivery of critical regulatory submissions.

Required Skills:

Preferred Skills:

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Current Contingent Workers apply HERE

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Job Posting End Date:

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