Regulatory Start Up Associate II

Novotech · Czechia

Apply on the company website

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?

More jobs at Novotech · Legal & Compliance jobs in Czech Republic