Global Regulatory Submissions Strategist

MSD; Ciudad de México; On-site; MXN 600,000 - 900,000; Full time

Job summary

MSD is seeking a Specialist, Global Submissions Publishing to support the end-to-end publishing process for regulatory dossiers. You will collaborate with authors and cross-functional teams to ensure timely, accurate submissions aligned with global health authority requirements.

The role requires publishing experience, English proficiency, and familiarity with industry tools. You will contribute to process improvements, mentoring, and documentation development within Regulatory Planning and

Qualifications

• Bachelor’s degree with 5+ years in publishing or regulatory content.
• Fluent English required.
• Publishing experience required.
• Familiarity with Veeva, Insight Publisher and Lorenz Docubridge.

Responsibilities

• Execute the comprehensive publishing process, including QC, verification, finalization, delivery and archiving of submission dossiers.
• Ensure timely completion of submission assemblies by deadlines to uphold project schedules.
• Collaborate with authors and stakeholders to ensure high-quality outputs and regulatory compliance.
• Test and evaluate new publishing tools and processes; provide feedback for improvements.
• Develop and maintain administrative documentation, SOPs, and training materials.
• Stay informed on industry trends and regulatory changes related to publishing sciences.
• Identify and mitigate risks; mentor inter-departmental and external stakeholders.

Skills

Interpersonal skills

Time management

Adaptability

Cultural sensitivity

Problem solving

Detail-oriented

Education

Bachelor’s Degree + 5 years of relevant experience

Tools

Veeva

Insight Publisher

Lorenz Docubridge

MS Word

Adobe Acrobat Pro

Job description

MSD is seeking a Specialist, Global Submissions Publishing to support the end-to-end publishing process for regulatory dossiers. You will collaborate with authors and cross-functional teams to ensure timely, accurate submissions aligned with global health authority requirements.

The role requires publishing experience, English proficiency, and familiarity with industry tools. You will contribute to process improvements, mentoring, and documentation development within Regulatory Planning and