Job Description

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About the Position:

The Regulatory Start Up Associate is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial approval.

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.
• Prepare and submit various regulatory and ethics documents, including Central EC/IRB applications, local EC/Governance applications, and Regulatory Authority applications.
• 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.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

About Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

About the Team: Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.

It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.

As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Novotech