Job Overview
Location
ZAF-Remote
Job Type
Full-time
Category
Other
Date Posted
April 8, 2026
Full Job Description
đź“‹ Description
- • The Sr Site Start-Up & Regulatory Specialist (Remote) South Africa role is critical to ensuring timely and compliant clinical trial site activation across South Africa, directly impacting patient access to innovative therapies by managing regulatory submissions, site feasibility, and operational delivery with minimal oversight.
- • Day-to-day responsibilities include forecasting submission timelines, preparing and submitting ethics and regulatory authority applications, managing site contracts and budgets, maintaining Trial Master File compliance, providing regulatory intelligence, supporting site selection, and mentoring junior team members on SOPs and local regulations.
- • Syneos Health is a global leader in integrated life sciences services, partnering with innovators across drug development and commercialization, with a mission to accelerate healthcare progress through a culture of inclusion, continuous learning, and purpose-driven delivery.
- • In this role, you will deepen your expertise in clinical trial regulatory affairs, gain hands-on experience in cross-functional site start-up operations, develop leadership and mentoring capabilities, and contribute to accelerating first-patient-in timelines for life-changing therapies.
🎯 Requirements
- • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field, or equivalent experience
- • Minimum 3–5 years of experience in clinical trial site start-up, regulatory affairs, or clinical operations within the pharmaceutical or CRO industry
- • Strong knowledge of South African regulatory requirements (SAHPRA, NHREC, local ECs) and ICH-GCP guidelines
- • Proven ability to manage multiple projects independently, track milestones, and escalate issues with clear rationale and contingency plans
- • Excellent communication, negotiation, and stakeholder management skills for interacting with sites, investigators, sponsors, and internal teams
- • Experience with Trial Master File (TMF) management, essential document preparation, and SOP/WI compliance
🏖️ Benefits
- • Career development and progression opportunities with technical and therapeutic area training
- • Supportive and engaged line management with peer recognition and total rewards program
- • Commitment to an inclusive culture where you can authentically be yourself
- • Opportunity to work with a global team of 25,000+ colleagues shaping the future of healthcare
- • Remote work flexibility based in South Africa
- • Exposure to diverse therapeutic areas and global clinical trial projects
Skills & Technologies
About Syneos Health, Inc.
Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.
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