Senior Regulatory Affairs Associate

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 ethics and regulatory authority applications during the start‑up phase of clinical trials and, where applicable, throughout study maintenance and close‑out. The role ensures all submissions comply with ICH‑GCP guidelines, local regulatory requirements, 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 local regulatory requirements and start‑up activities.

Responsibilities

• Independently manage country‑ and site‑level ethics and regulatory submissions for assigned clinical studies.
• Prepare, review, and coordinate Regulatory Authority, Ethics Committee (EC), and Institutional Review Board (IRB) submissions, amendments, notifications, renewals, and study close‑out activities.
• Ensure all submissions are completed in accordance with ICH‑GCP, local regulations, Novotech SOPs, and project timelines.
• Act as the primary Regulatory Start‑Up contact for assigned countries and collaborate closely with Project Managers, Clinical Operations, sponsors, and investigative sites.
• Provide guidance on country‑specific regulatory requirements and maintain awareness of changes to local regulations and industry practices.
• 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, or biotechnology environment.
• Strong knowledge of ICH‑GCP guidelines, EU Clinical Trial Regulation (CTR), and local regulatory requirements.
• Proven experience preparing and managing Regulatory Authority, Ethics Committee (EC), and IRB 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.
• Strong communication and stakeholder management skills with experience working across cross‑functional 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, CTIS, or other clinical systems is an advantage.
• Experience across Phase I‑III clinical trials is preferred.

Annual Salary

Euros 55,000 (final compensation will be aligned with the candidate's experience level).

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

We are looking for people who are passionate about clinical research and biotechnology, including people who identify as LGBTIQ+, have a disability, or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to responding to every application. We look forward to hearing from you.