Principal Regulatory Operations Publisher

📋 Description

• Independently lead regulatory publishing projects from planning through completion, ensuring timely
• Manage the finalisation, formatting, quality control, and publishing of regulatory documents for
• Coordinate with Medical Writing, Biostatistics, Programming, Regulatory Affairs, and other
• Independently manage major regulatory dossiers and submission amendments of varying complexity and
• Ensure regulatory documents comply with applicable publishing standards, technical requirements
• Represent the Regulatory Operations function in critical business activities and cross-functional

🎯 Requirements

• Bachelor’s degree, preferably in a scientific discipline.
• At least 8 years of relevant regulatory publishing experience within a contract research
• Advanced proficiency in Adobe Acrobat, ISIToolbox, and regulatory publishing software such as
• Strong expertise in Microsoft Word formatting, including advanced use of styles and templates, as
• Proven ability to independently manage complex regulatory publishing projects and lead project
• Experience with global regulatory submissions, including FDA and EMA requirements, is highly

🎁 Benefits

• Fully remote working opportunities, including eligibility for remote work from India.
• Competitive compensation, with salary determined according to location, skills, experience
• Performance-based bonus opportunities, where applicable.
• Flexible time-off arrangements.
• Paid holidays.
• Medical insurance, depending on location.