Regulatory Start Up Manager

Life Sciences WA; Melbourne; Presencial; AUD 90.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible working options

Paid parental leave

Flexible leave entitlements

Wellness programs

Professional development programs

Descripción de la vacante

Novotech is a global full-service clinical CRO seeking a Regulatory Start Up Manager to plan, drive and coordinate RSU activities across regions. You will partner with the Project Manager to ensure timely, compliant deliverables and seamless collaboration with local RSU teams, health authorities, and ethics committees.

The role requires a clinical/life sciences background with 3+ years in trial start-up/regulatory operations, excellent English, and strong planning, documentation, and

Formación

• Graduate in a clinical, pharmacy or life sciences-related field.
• At least 3 years’ experience from a CRO or the pharmaceutical industry in trial start-up/regulatory operations.
• Thorough knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• High proficiency in English.

Responsabilidades

• Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.
• Oversee the execution of regulatory start up for assigned projects in accordance with RSU strategy.
• Ensure collaboration with local regulatory start up teams to deliver the agreed project scope.
• Distribute start up documents to local RSU teams and customize core templates as needed.
• Oversee submission processes to health authorities, ethics committees and other bodies.
• Provide regional coordination to meet approval timelines.
• Oversee site activation package compilation and approvals.
• Identify risks to start up and escalate; develop RSU mitigation plans.
• Provide timely updates of RSU progress to the Project Manager.
• Present at internal and external meetings; act as client contact for RSU items.

Conocimientos

Regulatory start-up

Stakeholder management

Presentation skills

Decision making

Problem solving

Educación

Bachelor's degree in life sciences/clinical/pharmacy

Descripción del empleo

The Regulatory Start Up Manager is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client’s expectations.

Responsibilities

• Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.
• Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy.
• Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan.
• Distribute start up related documents to local regulatory start up teams.
  • Oversee customization of core start-up documents to local requirements.
  • Ensure preparation and distribution of core contract and budget templates to applicable team members.
  • Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines.
  • Oversee site activation package compilation and approvals.
• Proactively identify any risks to start up and Escalate to Project Manager. Develop RSU mitigation plans.
• Provide timely update of regulatory start up progress to Project Manager.
• Present at external and internal meetings including but not limited to project internal and external meetings, kick-off meetings.
• Serve as a client’s contact for regulatory start up related items.

Experience and Qualifications

• Graduate in a clinical, pharmacy or life sciences related field.
• At least 3 years’ experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations.
• Thorough knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• Strong presentation, documentation, and people skills.
• High proficiency in English.

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

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.

About the Team

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.

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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Job Info

• Job Identification 3885
• Job Schedule Full time
• Locations Level 13, 440 Collins Street,, Melbourne, Victoria, 3000, AU