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.

Experience and Qualifications

• Graduate in a clinical, pharmacy or life sciences related field.
• Experience managing start up in more than one country and/or region.
• At least 3 years’ experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations.
• Through knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• Competent working in virtual teams across time zones.
• 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

• 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