Regulatory Associate II

South San Francisco, CA 94080

Posted: 07/06/2018 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 4460
  • Regulatory Knowledge Has practical understanding of relevant HA guidelines, GSPs and expected submission requirements and content to manage the scope of activities and submissions assigned
  • Actively consults line management, SMEs and approved internal Regulatory Standards and information databases to ensure strong understanding of historical precedent for topics assigned General Organizational and Operational Knowledge
  • Knowledgeable in technical regulatory department processes required for scope of assignments (assigned by mgr)
  • Has sufficient technical understanding of process and product development processes to complete assignment within assigned scope
  • Executes work priorities and timelines with consultation of line mgr and TRL Submission Support Activities Coordinate activities required for submission generation and review
  • Ensure all technical regulatory submissions meet are accurate and have been checked for compliance as appropriate
  • Ensure submissions contain adequate scientific justifications to mitigate risks identified in the Readiness to Submit processes and TRT risk assessments
  • Ensures submission are performed per project timelines or timeless agreed with Health Authorities. Ensures all regulatory correspondence and submission-related documents are archived Communication
  • Effectively communicate with line mgr, TRT members and stakeholders to inform of project status and strategy in accordance with defined role
  • Communicates project challenges to line mgr in an appropriate and timely manner. Communicate internallly to facilitate the review and approval of submissions.
  • Displays high degree of capability in assigned written and oral presentation
  • Manage multiple projects independently
  • Work in teams in a matrix environment
  • Work with others to generate support for assigned projects
  • Apply Regulatory and relevant technical knowledge to projects.
  • Volunteer for new tasks and projects. 
  • Complete assigned tasks and projects with direct management oversight.
  • Communicate with regulatory, cross-functional personnel, partners and HA authorities in support of project goals under general supervision
  • Able to communicate drivers for project goals internally
  • Bachelor's degree or higher in a relevant scientific discipline.
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