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Regulatory Specialist

hace 2 meses

Xico, México Syneos - Clinical And Corporate - Prod A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Specialist to join our team at Syneos Health. As a key member of our Clinical Development team, you will be responsible for providing quality deliverables at the country level and ensuring compliance with project requirements and applicable country rules.

Key Responsibilities
  • Provide quality on deliverables at the country level and ensure compliance with project requirements and applicable country rules.
  • Work within forecasted submission/approval timelines and ensure milestones are tracked in real-time.
  • Monitor basic financial aspects of the project and escalate discrepancies in a timely fashion.
  • Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
  • Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
What We're Looking For
  • Associate's Degree or equivalent combination of education and training.
  • Good understanding of clinical trial process across Phases II-IV and ICH GCP.
  • Ability to interact effectively and appropriately with investigative site personnel.
  • Good organizational skills and attention to detail.
  • Ability to take direction from multiple individuals and set priorities accordingly.
Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.