Senior Regulatory Affairs Specialist – Regulatory Liaison

• Provide regulatory advice and carry out projects in the provision of regulatory affairs services
• Act as liaison with internal stakeholders in providing regulatory affairs services
• Perform day-to-day operational aspects of the Regulatory Affairs Department, including assessment of regulatory documents
• Prepare and assemble global regulatory submissions
• Conduct quality-control review of final submission packages
• Interface with PPD project teams and Health Authorities regarding regulatory strategy and submission activities
• Develop and maintain cooperative working relationships with Project Managers and project team members
• Advise and direct project teams on responsibilities related to regulatory strategy and submission activities
• Act as 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
• Previous Regulatory affairs experience
• Appreciation of the requirements, timelines and processes for regulatory applications globally is a valuable asset
• 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

• Fully remote work arrangement
• Standard Office Hours (40/wk)