Regulatory Start Up Associate I/Ii - Nz

Novotech; New Zealand; Vor Ort; NZD 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Flexible working options

Paid parental leave

Flexible leave entitlements

Wellness programs

Ongoing development programs

Zusammenfassung

Novotech is seeking a Regulatory Start Up Associate I/II in New Zealand to plan, prepare and review country- and site-level ethics and regulatory submissions during trial start-up, ensuring compliance with ICH-GCP and local requirements. The role requires at least 1 year of regulatory start-up experience in clinical industry and a degree in life sciences, pharmacy, or related field.

We offer flexible working options, paid parental leave, flexible leave entitlements, wellness programs and ongoing

Qualifikationen

• Experience in regulatory start-up activities for clinical trials.
• Graduate in clinical, pharmacy, or life sciences field.

Aufgaben

• Develop master and country ICFs, study forms and other documents for EC/IRB submissions and local regulatory authorities.
• Participate in start-up initiatives and help develop and maintain start-up processes, tools and SOPs; identify inefficiencies and propose improvements.

Kenntnisse

Regulatory Start-Up

Stakeholder management

Planning & organisation

Ausbildung

Bachelor's degree in life sciences / pharmacy / clinical field

Jobbeschreibung

Regulatory Start Up Associate I/II - NZ

Company : Novotech

Job Type : Full Time New Zealand

The Regulatory Start-Up Associate (RSA) 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 RSA 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 include:

• Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
• Participate in company start-up initiatives, contributing to development and maintenance of Regulatory Start Up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements.

Experience required:

• At least 1 years Regulatory Start Up experiences in local the clinical industry.
• Graduate in a clinical, pharmacy or life sciences related field.

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 contacting you regarding your application.