About this role
Responsibilities
Act as line manager for all assigned RSA staff; Ensure line reports are aware and understand company policies and procedures appropriate to their position. Ensure resource and recruitment are well aligned and timely managed in collaboration with relevant parties, participate in interviews for potential new hires. Ensure utilization and realization targets for RSAs are met.
Work alongside line reports by oversight, planning, preparation, reviewing and approving of EC and RA applications to ensure timely approval of clinical trials. Review and approve proposed packaging and labelling for investigational products. Preparation, review, and submission of importation and/or exportation licences and/or permits for investigational products.
Manage and track status of work and progress towards timelines for all projects. Monitor functional performance metrics. Participate in activities of the clinical services group including project manager and clinical team training and meetings.
Represent Regulatory Start-up operations at client and project team meetings, providing input to start up timelines and study plans. Act as local regulatory expert to facilitate local or regional clinical trial regulatory and ethics submissions and approvals and regulatory intelligence. Participate or lead company initiatives related to regulatory start-up activities.
Provide advice to BD and/or project teams on regulatory start up strategy and any aspects of EC and/or RA process for clinical trials. Participate in bid preparation and meetings for clinical trial services in conjunction with Novotech’s BD where necessary.
Minimum Qualifications & Experience
Graduate in a clinical, pharmacy or life-sciences related field and/or line management experience within the pharmaceutical industry.
- At least 10 years’ experience of working in the pharmaceutical industry or a related field.
- Clinical regulatory and start up knowledge and/or project management experience.
- CRO experience, line and/or matrix management experience are highly regarded.
- South Korea licensed Pharmacist highly regarded
- People Management experience is a must (more than 6 people team)
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 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 talking to you about working at Novotech.
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.
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