Regulatory Affairs and Study Initiation Specialist

il y a 4 semaines


Paris, Île-de-France Planet Pharma Temps plein

Position: Regulatory Affairs and Study Initiation Specialist

Duration: 4 Months

Location: France

Role Summary:

The successful candidate will be accountable for ensuring the timely and high-quality readiness of site activation within designated countries and sites, while proactively identifying and addressing potential risks.

Key Responsibilities:

  • Preparation of Clinical Trial Application Forms and submission dossiers (initial and amendments/notifications) to Competent Authorities, Ethics Committees, and other relevant local entities in accordance with local regulations and timelines to secure all necessary approvals for conducting Clinical Trials, adhering to international and local/national regulations, company SOPs, and ICH-GCP principles.
  • Engagement with Competent Authorities and Ethics Committees for study-related matters and managing their responses.
  • Providing consistent updates regarding submissions to the Start-Up Lead and/or Regulatory Lead assigned to the study, as well as to the Project Manager/Project Team.
  • Maintaining project plans, trackers, and regulatory intelligence tools related to assigned duties, ensuring effective communication with Regulatory Leadership.
  • Assisting in the development of study-specific start-up plans, IMP release requirements, and criteria for essential document review.
  • Collaborating with the assigned site Clinical Research Associate (CRA) to ensure cohesive communication and secure site readiness.

About Planet Pharma:

Planet Pharma is a leading American Employment Business/Agency specializing in global staffing solutions, with headquarters in Chicago and a regional office in Central London. We have established a strong international framework that allows us to operate compliantly in over 30 countries, supported by a network of more than 2500 active contractors worldwide, alongside a robust permanent/direct hire recruitment service.

Our unique position in the industry is bolstered by our extensive expertise and strong relationships with clients. Recently, we were recognized by FORBES as the 17th best professional staffing firm and have received multiple accolades from industry bodies for our commitment to excellence and service delivery. Our areas of specialization include Regulatory Affairs, Pharmacovigilance, Quality Assurance, Quality Control, Submissions, Clinical Development, Biostatistics, and Medical Affairs/Writing.

We are an equal opportunity Recruitment Business and Agency, welcoming applications from all qualified candidates regardless of race, sex, disability, religion/belief, sexual orientation, or age.



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