Associate Specialist, Global Submissions Publishing

About the role

The Associate Specialist in Global Submissions Publishing supports the Regulatory Planning and Publishing team by assembling, verifying, and delivering high‑quality regulatory dossiers to health authorities. The role ensures timely completion of submission components in line with global regulatory policies.

Key responsibilities

• Execute the full publishing process, including quality control, verification, finalization, delivery, and archiving of submission dossiers.
• Collaborate with authors, contributors, and stakeholders to ensure high‑quality outputs and meet project deadlines.
• Participate in testing and implementation of new publishing tools and processes, providing feedback for improvements.
• Assist in creating and maintaining administrative documentation such as SOPs, guidelines, and training materials.

Required profile

• High School Diploma or equivalent.
• Strong interpersonal and communication skills, with ability to work collaboratively across cultures.
• Excellent time‑management and organizational abilities to handle multiple time‑sensitive assignments.
• Adaptability to changing environments and processes.

Required skills

• Proficiency with MS Word.
• Experience using Adobe Acrobat Professional.
• Knowledge of Electronic Common Technical Document (eCTD) processes.
• Familiarity with document control and management systems.