About the Role
The Regulatory Start-Up Lead (RSL) are 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 maintenance and close-out. They ensure that all submissions comply with ICH-GCP guidelines and local regulatory requirements to support timely trial approvals.
The RSL has an action-oriented mindset to proactively address challenges and advance start-up activities. The ability to balance stakeholders is essential, considering ethical, cultural, and organizational needs. Strong planning and alignment skills ensure activities are structured and adaptable to change.
Responsibilities
- Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) and/or sites for country and site level start up activities on allocated projects.
- Provide expertise and guidance to RSM/PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.
- Work within the scope of the Regulatory Start Up plan or other applicable project plan, relevant SOPs, and ICH-GCP.
- Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
- Comprehensive, specialised knowledge within the field of work, able to use the knowledge to solve problems, and make judgements within own scope of work.
- Functions as a member of cross-functional/cross-country working teams, especially with Project Management and Clinical Operations teams in assigned countries.
- Acts as regional/multi-country regulatory lead, coordinates local teams across sub-regions, and collaborates with Project Manager and/or Regulatory Start Up Manager to ensure strategic priorities are understood and implemented.
- Ensures that start-up activities are undertaken in accordance with agreed timelines, allocated budgets, required quality standards and company policies and procedures.
- May participate in bid defence meetings and/or support proposals with ethics/regulatory intelligence and start up strategies and timelines.
- Subject Matter Expert on local and/or regional ethics/regulatory processes and requirements or specific start-up task(s).
- Lead or participate in initiatives to drive overall performance improvement, quality and customer experience.
- May participate in vendor Audits including presenting on Novotech Regulatory Start Up SOPs and processes.
- Serve mentor to junior team members and as a back-up line manager.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related discipline.
- 5+ years of experience in Clinical Research, Regulatory Affairs, or Clinical Trial Start-Up within a CRO, pharmaceutical, or biotechnology environment.
- Proven experience managing country-level and multi-country regulatory and ethics submissions for clinical trials.
- Strong knowledge of ICH-GCP guidelines and global/local regulatory requirements.
- Experience with Clinical Trial Applications (CTAs), Ethics Committees (ECs), Institutional Review Boards (IRBs), and Regulatory Authority submissions.
- Demonstrated experience supporting clinical trial start-up from planning through regulatory approval.
- Strong understanding of regional regulatory requirements and submission processes.
- Excellent project management, planning, and organisational skills with the ability to manage multiple priorities.
- Strong stakeholder management and communication skills, with experience collaborating across cross-functional and international teams.
- Ability to identify risks, solve problems proactively, and drive regulatory timelines.
- Experience mentoring junior team members or leading regional start-up activities is highly desirable.
- Proficiency with clinical systems such as eTMF, CTMS, or regulatory document management platforms is an advantage.
- Experience in Phase I–III clinical trials across multiple therapeutic areas is preferred.
Annual Salary: RON 280,000 (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 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 programs.
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. We look forward to contacting you regarding your application.
About Us
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.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our 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.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
Skills Required
- 5+ years experience in a Regulatory Start Up role in the clinical trial industry.
- Graduate degree in a clinical, pharmacy, or life sciences related field.
- Knowledge of ICH-GCP guidelines and local regulatory requirements for clinical trial submissions.
- Experience coordinating cross-functional and multi-country teams and acting as a regional/multi-country regulatory lead.
- Ability to manage start-up timelines, allocated budgets, and required quality standards.
- Participation in or support for bid defence meetings and proposals with ethics/regulatory intelligence (may be required).
- Action-oriented mindset with strong stakeholder management, planning and alignment skills.
What We Do
Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, "Novotech" and "PPC". Novotech is a full-service clinical CRO with labs, phase I facilities, and drug development consulting services.
