Job Description

About the Role

The Senior Regulatory Start-Up Associate (Senior RSA) is responsible for the planning, preparation, coordination, and submission of country- and site-level regulatory and ethics applications during the start-up phase of clinical trials and, where applicable, throughout study maintenance and close-out.

The role ensures that all submissions comply with ICH-GCP, South African Good Clinical Practice (SA GCP) guidelines, SAHPRA requirements, applicable South African regulations, and Novotech or client SOPs to support timely study activation.

The Senior RSA is a fully competent regulatory professional who works with a high degree of autonomy while managing multiple studies and competing priorities. The role also supports continuous process improvement, mentors junior team members, and serves as a subject matter expert on South African regulatory requirements and clinical trial start-up activities.

Responsibilities

• Independently manage country- and site-level regulatory and ethics submissions for assigned clinical studies in South Africa.
• Prepare, review, and coordinate SAHPRA, Research Ethics Committee (REC), and other applicable regulatory and ethics submissions, including initial applications, amendments, notifications, renewals, and study close-out activities.
• Ensure all submissions are completed in accordance with ICH-GCP, South African GCP guidelines, applicable local regulations, SAHPRA requirements, Novotech SOPs, and project timelines.
• Act as the primary Regulatory Start-Up contact for assigned studies and collaborate closely with Project Managers, Clinical Operations, sponsors, investigators, and investigative sites.
• Provide guidance on South African regulatory and ethics requirements and maintain awareness of changes to local regulations, guidelines, and industry practices.
• Support the preparation and submission of clinical trial applications to SAHPRA and coordinate applicable ethics submissions with the relevant Research Ethics Committees.
• Support applicable clinical trial registration requirements, including the South African National Clinical Trials Register (SANCTR), where required.
• Manage multiple studies simultaneously while ensuring quality, compliance, and on-time delivery.
• Maintain accurate regulatory documentation and submission trackers within applicable clinical systems.
• Participate in company Regulatory Start-Up initiatives and contribute to the development and maintenance of processes, tools, templates, and SOPs.
• Identify process inefficiencies and recommend improvements to enhance quality and operational efficiency.
• Assist with the development and delivery of Regulatory Start-Up training in collaboration with the Learning & Development team.
• Mentor and support junior Regulatory Start-Up Associates.
• Serve as the local Subject Matter Expert (SME) on specialised regulatory and start-up activities.
• Where applicable, act as the RSA Country Lead on projects without a dedicated Regulatory Start-Up Manager (RSM).
• Participate in cross-functional and cross-country project teams to support successful study start-up.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related discipline.
• At least 3–5 years of Regulatory Start-Up experience within a CRO, pharmaceutical, biotechnology, or related clinical research environment.
• Strong knowledge of ICH-GCP and South African GCP guidelines, with a good understanding of applicable South African clinical trial regulations and requirements.
• Proven experience preparing and managing SAHPRA and Research Ethics Committee submissions.
• Demonstrated ability to independently manage the full range of Regulatory Start-Up activities with minimal supervision.
• Experience supporting multiple clinical studies across various therapeutic areas.
• Excellent organisational and project management skills, with the ability to manage competing priorities and meet study timelines.
• Strong communication and stakeholder management skills, with experience working across cross-functional and international teams.
• Ability to identify risks, solve problems proactively, and drive study start-up timelines.
• Experience mentoring junior team members is highly desirable.
• Proficiency with CTMS, eTMF, regulatory submission platforms, or other clinical systems is an advantage.
• Experience across Phase I–III clinical trials is preferred.
• Previous experience with SAHPRA clinical trial submissions and South African Research Ethics Committees is highly desirable.

Annual Salary

ZAR 800,000 gross per annum

Final compensation will be aligned with the candidate's experience, qualifications, and internal salary framework.

About Novotech

Novotech is proud to offer a great workplace. We are committed to being an employer of choice and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand that work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave, flexible leave entitlements, wellness programs, and ongoing development opportunities.

We are looking for people who are passionate about clinical research and biotechnology and who want to contribute to the development of new medicines and therapies.

We are committed to creating an inclusive workplace where everyone can bring their authentic selves to work. We welcome applications from people from diverse backgrounds and experiences.

We look forward to hearing from you.