PPD is recruiting for an experienced Senior or Principal Regulatory Affairs Specialist.
In this role you will provide regulatory advice and carry out projects in the provision of regulatory affairs services. You will also act as liaison with internal and external clients in the provision and marketing of regulatory affairs services.
Responsibilities include but are not limited to:
Functioning as Regulatory Affairs Lead on global projects
Performing the day to day operational aspects of the department
Interfacing with PPD project teams, sponsors and the FDA
Coordinate regulatory submission activities for assigned projects
Develop collaborative working relationships with Project Manager and project team members
Act as primary liaison between the department, project teams, and the client
Education and Experience Requirements:
- Significant regulatory affairs experience preferrably with global understanding of clinical trials - Ideally candidates will have a degree (or equivalent) - Knowledge and understanding of ICH and global regulatory guidelines, preferred - Experience managing and leading projects
Knowledge, skills and abilities:
- Strong interpersonal, organizational and planning skills - Ability to adapt quickly, and with support, lead clinical trial projects - Ability to confidently perform in client facing role - Excellent verbal and written communication skills - Enjoys working in a team setting - Comfortable working autonomously