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About the Role
The Senior Regulatory Start-Up Associate (SRSA) plans, prepares, and reviews country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials. They ensure compliance with ICH-GCP guidelines and local regulatory requirements for timely trial approvals. The role requires an action-oriented mindset, strong planning and alignment skills, and the ability to balance ethical, cultural, and organizational needs.
Responsibilities
- Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
- Participate in company start-up initiatives, contributing to development and maintenance of Regulatory Start Up processes, tools and SOPs.
- Identify areas of inefficiency in process and make recommendations for improvements.
- Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager.
- Serve as a mentor to junior RSAs.
- Serve as the local subject matter expert on specialised aspects of regulatory and start up activities.
Requirements
- At least 3 years Regulatory Start Up experience within the ANZ clinical industry.
- Graduate in a clinical, pharmacy or life sciences related field.
Skills
- ICH-GCP guidelines
- local regulatory requirements
- Strategic mindset
- Proactive decision making
- Partnership and collaboration
Location
- ANZ
Work Type
- Full-time
Experience Level
- Senior
Education Level
- Graduate
Benefits
- Flexible benefits framework (NovoLife)
- Mentorship opportunities
- Professional development programs
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- Novotech is a globally recognized leader in clinical research and scientific advisory services.
- Award-winning workplace culture that values ambition, innovation, and growth.
- Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE).
- Fostering an environment that reflects the life-changing work they do.
- Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
- Uniting professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
- Advanced therapeutic and regulatory expertise.
- Ability to execute across markets.
- Client-centric service model.
- Trusted, long-term partner.
- Accelerated path to bring life-changing advances to market.
- Diverse and supportive global organization with a collaborative culture.
- Working with clients on the cutting-edge of life sciences.
- Empowered teams with a shared commitment to success.