Regulatory Start Up Associate Ii

4 months ago


Auckland City, New Zealand Novotech Asia Full time

**Minimum Qualifications & Experience**
- Graduate in a clinical, pharmacy or life sciences related field
- At least 1-2 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment

**Responsibilities**:

- Responsible for quality start-up deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the RSM or PM
- May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities.
- Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents.
- Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required.

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.



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