Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

In this role as a Sr Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy technical/project leadership on a regional/global level

In particular, the

Sr Regulatory Affairs Specialist

• Provides regulatory advice and carries out projects in the provision of regulatory affairs services:
• Acts as liaison with internal stakeholders in the provision of these services.
• Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: assessment of regulatory documents, preparation and assembly of global regulatory submissions, QC review of the final submission package.
• Interfaces with PPD project teams and Health Authorities regarding regulatory strategy/submission activities.
• Develops and maintains a cooperative working relationship with Project Managers and project team members for assigned projects.
• Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities.
• Acts as a key liaison between Regulatory Affairs Department and project team 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
• An 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) and 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