Regulatory Affairs Expert with Study Start-Up Focus

hace 3 semanas


Madrid, Madrid, España Ergomed A tiempo completo
About the Role

As a Regulatory Affairs Expert with a focus on Study Start-Up, you will play a critical role in ensuring timely and successful regulatory submissions to authorities such as the FDA and EMA. Your primary responsibilities will include preparing and reviewing regulatory information and documents, coordinating with investigative sites, and participating in informed consent form development and approval processes.

Key Responsibilities
  • Support the Regulatory Lead in project site-specific submission/approval timelines and ensure they are met; provide clear rationale for delays and contingency plans to mitigate impact.
  • Prepare, collect, review, and track essential documents to facilitate efficient site initiation and activation.
  • Collect, review for completeness and compliance, and investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information.
Requirements

To be successful in this role, you will require:

  • A strong understanding of regulatory requirements and guidelines.
  • Excellent communication and organizational skills.
  • Ability to work independently and collaboratively as part of a team.
What We Offer

We offer a competitive salary of $80,000 - $110,000 per year, depending on experience, as well as a comprehensive benefits package including health insurance, retirement plan, and paid time off. If you are a motivated and detail-oriented individual who is passionate about regulatory affairs, we encourage you to apply.



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