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Regulatory Start Up Associate

2 weeks ago

Singapore Novotech Asia Full time

**About the Position**:
**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**:

- Act as primary contact for Regulatory Start Up Manager and/or Project Manager during start-up phase of assigned projects.
- Provide guidance and expertise on local regulations and practices for clinical trial approvals in relevant countries.
- Ensure compliance with relevant SOPs, ICH-GCP and submission/approval timelines.
- Review and follow-up on comments/questions from reviewing bodies and prepare and submit ongoing amendments, notifications, safety reports, and study-related materials as required.
- Perform country and site Informed Consent Form (ICF) customization, review proposed packaging and labeling, and manage import/export licenses and official clinical trial registry registration.

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.