Job Description

Position Title
Associate Specialist, Global Submissions Publishing (GSP)

Department

Regulatory Planning and Publishing (RPP)

Brief Description of Position
Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hardcopy submissions.

Submission Publishing is responsible for assembling, linking, and delivering high-quality regulatory dossiers to health authorities, facilitating expeditious agency reviews that align with industry cycle times.

Key Responsibilities of Submission Publishing:
• Submission Activities Support: Execute the comprehensive publishing process, including quality control, verification, finalization, delivery of submission dossiers, and archiving to ensure compliance with industry standards and regulatory requirements.





• Timely Completion of Submission Assemblies: Ensure that all dossiers are finalized and submitted by the specified deadlines to uphold project schedules and achieve organizational objectives.

Shared Responsibilities:
• Collaboration: Collaborate with authors, contributors, and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success.

• Testing and Implementation of New Tools and Processes: Engage in the testing and evaluation of recent publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness.

• Development of Administrative Documentation: Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines, and training materials to support publishing processes.

• Continuous Learning and Development: Stay informed about industry trends, best pract

📌 Associate Specialist, Global Submissions Publishing (Hyderabad)
🏢 Msd
📍 Hyderabad