Principal Regulatory Affairs Specialist – Regulatory Liaison

• Provides regulatory advice and carries out projects in the provision of regulatory affairs services
• Acts as liaison with internal stakeholders in the provision of regulatory affairs services
• Performs day-to-day operational aspects of the Regulatory Affairs Department, including assessment of regulatory documents, preparation and assembly of global regulatory submissions, and QC review of final submission packages
• Interfaces with PPD project teams and Health Authorities regarding regulatory strategy and submission activities
• Develops and maintains cooperative working relationships with Project Managers and project team members for assigned projects
• Advises and directs project teams regarding responsibilities related to regulatory strategy and submission activities
• Acts as a key liaison between the Regulatory Affairs Department and project teams for assigned projects

• Bachelor's Degree; degree in Pharmacy or Life Science is an advantage
• Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered
• Some regulatory affairs experience is preferable but not mandatory
• Appreciation of requirements, timelines and processes for regulatory applications globally
• Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage
• Excellent English language communication skills, both verbal and in writing
• Computer skills (Microsoft Office)
• Experience in applications used in clinical trials (eTMF, CTMS) would be an advantage
• Good organizational and planning skills
• Ability for multiple project tasking
• Proven ability to work effectively in a team, including in a multinational one
• Problem solving skills and strong attention to detail