Regulatory Start Up Associate

As a Regulatory Start-Up Associate (RSA), you will be responsible for the planning, preparation and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials and, where applicable, throughout study maintenance and close-out.

You will ensure that all submissions comply with ICH-GCP guidelines and local regulatory requirements, supporting timely trial approvals and successful study start-up.

The RSA/RSL should have an action-oriented and proactive mindset, with the ability to identify challenges, find solutions and keep start-up activities moving forward. Strong stakeholder management skills are essential, with the ability to balance ethical, cultural and organisational needs.

Key Responsibilities

• Provide expertise and guidance to RSMs/PMs on country-specific regulations, requirements and practices.
• Stay up to date with changes in clinical trial regulations, guidelines and approval processes.
• Work in line with the Regulatory Start-Up Plan, applicable SOPs and ICH-GCP requirements.
• Provide country- and site-level information on submission requirements, deadlines and approval timelines.
• Prepare and submit Central EC/IRB, Local EC/Governance, Regulatory Authority and other required submissions.
• Ensure submission packages are complete, accurate and compliant with local requirements.
• Manage regulatory authority and ethics committee questions, comments and requests for information, ensuring timely responses.
• Support ongoing amendments, notifications, safety reports and other regulatory submissions as required.
• Perform country- and site-level Informed Consent Form (ICF) customisation, including translation coordination and review.
• Support site activation activities, including essential document collection, review and submission.
• Support Clinical Contracts Specialists with country and site budgets and CTA negotiations.
• Review and approve clinical trial packaging and labelling for local compliance.
• Prepare and manage import/export licence applications and customs clearance where required.
• Register clinical trials on applicable official registries and maintain registrations as required.
• Maintain accurate and up-to-date regulatory and study information in clinical trial management systems.
• Ensure regulatory and ethics documentation is complete and accurately filed in the TMF.
• Proactively escalate issues that may impact project timelines and provide appropriate mitigation plans.
• Maintain professional communication with clients, investigators, sites and internal stakeholders.
• Undertake additional responsibilities as assigned by the Line Manager.

About You

• 1–3 years of Regulatory Start-Up experience within the clinical research industry, or equivalent experience in another clinical research role.
• Degree in Clinical, Pharmacy, Life Sciences or a related field.
• Able to work independently with general supervision.
• Strong organisational and time-management skills, with excellent attention to detail.
• Able to manage multiple priorities and deliver high-quality work within agreed timelines.
• Proactive and solution-oriented approach to regulatory and start-up challenges.
• Strong communication and stakeholder management skills.
• Ability to work effectively within a global, multicultural and collaborative environment.

Why Novotech?

At Novotech, we are committed to creating an inclusive workplace where everyone is treated fairly and with respect. Our employees are passionate about the work we do, while recognising the importance of maintaining a healthy balance between work and life.

We support our employees through:

• Flexible working options
• Paid parental leave for both parents
• Flexible leave entitlements
• Wellness programs
• Ongoing professional development and training
• Mentoring and career development opportunities
• A collaborative and supportive global environment

We welcome applications from people with diverse backgrounds and experiences, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

About Novotech

Novotech is a global full-service Contract Research Organization (CRO) providing clinical research and scientific advisory services to the biotechnology and pharmaceutical industries.

Since 1997, we have expanded our global footprint to 30+ offices across Asia-Pacific, the United States and Europe. Our diverse teams work together to advance therapies that improve patient outcomes worldwide.

At Novotech, ambition meets opportunity. We combine advanced therapeutic and regulatory expertise with a client-centric service model, giving our employees the opportunity to work with innovative life sciences companies and develop their careers within a supportive global organisation.

Our culture is built around:

• Strategic thinking and a proactive mindset
• Partnership and collaboration
• Empowered teams and shared accountability
• Open communication where every voice is heard and valued
• Ongoing support from senior stakeholders and leadership

Join Novotech and be part of a team helping bring life-changing therapies to patients faster.

Salary Band – RSA II: 650,000 to 900,000 CZK. Salary offered will be based on the candidate’s experience level.

Novotech is proud to offer a great workplace and is 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 a Circle Back Initiative Employer and commit to responding to every application. We look forward to contacting you regarding your application.

Novotech is a global full-service clinical Contract Research Organization (CRO).

At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are 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), we are committed to fostering an environment that reflects the life-changing work we do.

Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.

At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.

With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.