Country Approval Expert

Há 4 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$54.000 - R$76.000

Improve Health Outcomes as a Regulatory Specialist

About the Role

This position plays a pivotal role in facilitating site activation and patient access for our clients. As a regulatory specialist, you will provide strategic advice on local regulations and ensure compliance with submissions and timelines.

Responsibilities
  • Provide Local Regulatory Guidance: Offer expert advice to internal clients on local regulatory requirements and strategies.
  • Coordinate Site Services: Coordinate project-specific local services and activities to meet client needs.
  • Maintain Regulatory Knowledge: Stay up-to-date with PPD SOPs, client SOPs/directives, and current regulatory guidelines to ensure accurate and timely maintenance of trial status information onto PPD tracking databases.

You will work closely with the start-up CRA to prepare regulatory compliance review packages and develop country-specific Patient Information Sheet/Informed Consent form documents. This role also involves assisting with grant budgets and payment schedules negotiations with sites.

In this capacity, you will be responsible for ensuring accurate and timely maintenance of trial status information onto PPD tracking databases.

Career Growth Opportunities

This role offers opportunities for career growth into various positions such as Senior Regulatory Specialist, Feasibility Specialist, or Site Contract Specialist. You may also pursue a management career track within our Global Clinical Development group.

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