Senior Associate, Regulatory Affairs

The Denali Regulatory Affairs Senior Associate, reporting to a Senior Program Manager, is a highly motivated, organized, and detail-oriented individual. The RASA will be responsible, with project lead oversight, for executing health authority submissions, providing project team support, and engaging in regulatory intelligence activities and department initiatives. The RASA will also have the opportunity to lead regulatory projects with appropriate oversight. Denali is seeking candidates with a can-do attitude who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven decision making.

Primary responsibilities

  • Executes with project lead oversight in preparation, submission, and maintenance of regulatory applications, including investigational new drug applications (IND), ex-US clinical trial applications (CTA), routine amendments, annual reports, etc.
  • Attends cross functional project team meetings
  • Liaises with external vendors in support of regulatory document management
  • Supports project lead in development of regulatory strategy
  • Performs regulatory intelligence research
  • Supports and/or leads various departmental initiatives with oversight
  • Complies with relevant governing laws, regulations, guidelines, and Denali SOPs

Qualifications and Experience

  • 2+ years regulatory experience or equivalent
  • Bachelor's degree required, advanced degree and life sciences background preferred
  • Basic working knowledge of US and/or EU regulations and guidance (both regions preferred)
  • Excellent written and verbal communication and collaboration skills
  • Strong ability to prioritize workload
  • Demonstrated ability to be proactive in identifying potential issues
  • Experience in IND or CTA filings a plus

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