Senior SSU Associate role in China. Lead clinical trial regulatory submissions & site activation. 4+ yrs SSU/regulatory exp & strong NMPA/ICH-GCP knowledge required. Apply now.
Accelerate Clinical Trials: Lead Regulatory Start-Up Excellence in China
At ICON, we are pioneers in clinical development, dedicated to turning scientific discovery into life-changing therapies. The journey of every new treatment begins with a critical phase: Study Start-Up (SSU). This is where strategy meets execution, and regulatory pathways are navigated with precision.
We are seeking an experienced and proactive Senior Study Start-Up Associate to join our high-performing team in China. In this pivotal role, you will be the operational leader driving the regulatory and ethical submission process for clinical trials, ensuring rapid and compliant site activation. Your expertise in NMPA regulations and ICH-GCP will be instrumental in turning study protocols into active, recruiting sites. If you are a regulatory specialist passionate about accelerating clinical research and thrive in a fast-paced, collaborative environment, this is your opportunity to shape the future of drug development in China.
Your Mission: The Architect of Compliant & Efficient Trial Activation
As a Senior SSU Associate, you will own the start-up timeline and deliverables for assigned studies. You will be the central point of coordination for all regulatory and ethical submissions, leveraging your expertise to navigate complexities and drive studies from protocol to first patient in.
Key Responsibilities
1. Lead Regulatory Strategy & Submissions
- Serve as the primary lead for all regulatory and ethics submission activities in China, including the preparation, compilation, and submission of Clinical Trial Applications (CTAs), amendments, and safety reports to the NMPA and local Ethics Committees (ECs).
- Interpret and apply complex NMPA regulations, ICH-GCP guidelines, and local requirements to ensure compliant and successful submissions.
- Manage direct communication and correspondence with regulatory agencies and ethics committees, serving as a key point of contact.
2. Project Management & Stakeholder Coordination
- Develop and manage detailed SSU timelines and trackers, proactively identifying risks and implementing mitigation strategies to keep studies on schedule.
- Coordinate seamlessly with internal cross-functional teams (Clinical Operations, Feasibility, Contracts) and external stakeholders (sites, vendors) to collect necessary documents and align on submission strategy.
- Provide expert guidance and training to study teams and junior staff on regulatory requirements and SSU best practices.
3. Process Excellence & Documentation
- Maintain impeccable, audit-ready records of all regulatory submissions, approvals, and correspondence in relevant systems (e.g., eTMF).
- Contribute to and lead process improvement initiatives aimed at streamlining SSU workflows, reducing cycle times, and enhancing the quality of submissions.
- Act as a subject matter expert (SME) during internal audits and regulatory inspections related to start-up activities.
Who You Are: The Ideal Candidate
You are a detail-oriented, process-driven professional with deep, hands-on experience in the Chinese regulatory landscape. You are a natural project manager, an effective communicator, and a problem-solver who is motivated by the challenge of accelerating trial start-up.
Your Required Profile:
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
- Minimum of 4-7 years of direct experience in Study Start-Up, Regulatory Submissions, or Clinical Trial Administration within a pharmaceutical company, biotech, or global CRO, with a strong focus on China.
- In-depth, practical knowledge of NMPA regulations, ICH-GCP, and local EC submission processes.
- Proven track record of successfully preparing and submitting CTAs and managing approvals from NMPA and ethics committees.
- Excellent organizational and project management skills, with the ability to prioritize and manage multiple complex studies simultaneously.
- Strong communication and interpersonal skills; fluency in English and Mandarin is essential for effective collaboration with global teams and local authorities.
- Proficiency with clinical trial management systems (CTMS) and document management systems (eTMF).
Why Build Your SSU Career at ICON in China?
1. Impact at the Critical Path
- Your work directly determines how quickly life-changing therapies can enter clinical testing in a key global market.
- Play a strategic role in one of the world’s most dynamic and complex regulatory environments.
2. Recognized Expertise & Career Growth
- Develop into a recognized regulatory and SSU expert within a global industry leader.
- Clear pathway to Team Lead, SSU Manager, or Regulatory Affairs positions.
3. Competitive Benefits & Collaborative Culture
- Competitive salary and performance-based bonus.
- Hybrid/office-based working model with modern facilities.
- Generous annual leave and comprehensive health insurance.
- Global Employee Assistance Programme and a culture that values innovation, inclusion, and professional development.
Join a Team Dedicated to Starting Trials Right
At ICON, we believe that a strong start leads to a successful finish. We are committed to creating an inclusive environment and encourage all qualified regulatory and SSU professionals across China to apply.
Ready to be the driving force behind faster, smarter trial activation in China?
If you are an SSU expert with a passion for regulatory strategy and execution, apply now.
