Regulatory Specialist II

3 weeks ago

Montreal, Quebec, Canada Syneos Health Full time
About the Role

Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

As a Regulatory Specialist II - Clinical Trial Start-Up, you will play a critical role in ensuring the quality of our clinical trials. You will be responsible for managing external vendors, preparing and submitting regulatory documents, and ensuring compliance with ICH GCP and local regulations.

Key Responsibilities
  • Manage external vendors to contract effectively and ensure timely delivery of regulatory documents.
  • Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
  • Monitor and track milestone progress in real-time and investigate delays, providing clear rationale and support for contingency plans.
  • Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, ensuring timesheet compliance and maintaining training records.
  • Support continuous improvement of quality in all Site Start-Up (SSU) components at the country level, including submissions, essential document collection, communication to Competent Authorities and ECs, etc.
Requirements
  • Bachelor's Degree
  • Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
  • Ability to understand clinical protocols and associated study specifications
  • Detailed understanding of clinical trial start-up processes
  • Ability to manage multiple project budgets with increased complexity and value
  • Quality-driven in all managed activities
  • Good negotiating skills
  • Good problem-solving skills
  • Demonstrated ability to work independently as well as part of a team
What We Offer

Syneos Health is committed to developing our people through career development and progression, technical and therapeutic area training, peer recognition, and a total rewards program. We are passionate about creating a workplace where everyone feels like they belong, and we are dedicated to taking care of our people.

We are a global organization with a diverse team of professionals, and we are committed to building a workplace that reflects the diversity of our customers and the communities we serve. If you are a motivated and detail-oriented individual who is passionate about clinical trials and regulatory compliance, we encourage you to apply for this exciting opportunity.

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