Regulatory Start Up Associate

1 week ago


กรงเทพมหานคร, Thailand 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**:

- Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects.
- Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries
- Work within the scope of the Regulatory Start Up plan or other applicable project plan, relevant SOPs, and ICH-GCP.
- Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate

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 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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