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Open nowPosted 22 days ago

Regulatory Start Up Associate II

Novotech Global85 open roles

Where
Taiwan
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Your applicationOpen nowRegulatory Start Up Associate IINovotech Global · Taiwan

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The clock on this job

Early applications get read.

13.4% of postings close within 7 days. Measured by our own scanner across the market. Novotech Global postings stay open a median of 21 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.6%3 days
  3. 13.4%7 days
  4. 21.6%14 days
  5. 36.2%30 days
  6. 59.0%60 days
This job: posted 22 days ago

Novotech Global median: 21 days open

The posting

Job Description

The Regulatory Start-Up Associate (RSA) and Regulatory Start-Up Lead (RSL) 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 / RSL 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.

Responsibilities

Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) and/or sites for country and site level start up activities on allocated projects.

  • Provide expertise and guidance to RSM/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.
  • Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals.
  • May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities.
  • Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
  • Ensure submission packages are accurate and complete per local requirements.

Qualifications

  • 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.
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