Clinical Regulatory Specialist

Syneos Health is seeking a Clinical Regulatory Specialist to work in a fast-paced environment. The successful candidate will be responsible for providing delivery and expertise in country ethics and regulatory submissions from startup until project end.

Job Responsibilities

The Clinical Regulatory Specialist will serve as the main country-level contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs) under the direction and supervision of the Project Lead (PL), Regulatory Lead (RL), or Site Activation Manager (SAM).

Key responsibilities include:

• Providing quality deliverables at the country and site level
• Maintaining expert knowledge of RA/EC processes, requirements, and timelines
• Providing country-level SME knowledge at the pre-award stage to support robust business development presentations
• Preparing and submitting Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions as required
• Directly interacting with RAs and ECs, identifying solutions when issues arise
• Serving as the country-level regulatory SME point of contact through the life of assigned projects

Qualifications

The ideal candidate will have:

• A minimum of a BA or BS degree
• 3-4 years of experience working in a Clinical Research environment
• Detailed understanding of clinical trial process across Phases I-IV and ICH GCP
• Strong organizational and problem-solving skills, with a proven ability to meet deadlines with high quality
• Strong presentation, documentation, influencing, and communication skills

Benefits

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.