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About the Role

The Regulatory Start-Up Associate (RSA) and Regulatory Start-Up Lead (RSL) are responsible for planning, preparing, and reviewing 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 stakeholder balancing skills, and excellent planning and alignment abilities.

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.
Participate in company start-up initiatives, contributing to the development and maintenance of Regulatory Start Up processes, tools and SOPs.
Identify areas of inefficiency in processes 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 specialized aspects of regulatory and start up activities.

Requirements

At least 3 years Regulatory Start Up experience in the local clinical industry.
Graduate in a clinical, pharmacy or life sciences related field.

Skills

Strategic mindset
Ability to gain insights and make proactive decisions quickly
Culture that fosters partnership and collaboration
Ability to balance stakeholders
Strong planning and alignment skills

Experience Level

3 years Regulatory Start Up experience

Education Level

Graduate in a clinical, pharmacy or life sciences related field

Benefits

Flexible working options
Paid parental leave for both parents
Flexible leave entitlements
Wellness programs
Ongoing development programs
NovoLife, our flexible benefits framework

About the Company

Novotech is a global full-service clinical Contract Research Organization (CRO).
Novotech is proud to combine our position at the forefront of the industry with an 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).
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe.
Our growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare.
Novotech has advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model.
We offer a trusted, long-term partner and an accelerated path to bring life-changing advances to market.
We provide employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.

Equal Opportunity

We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application.