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Regulatory Associate IV
Ref No.: 18-03938
Location: South San Francisco, California
This is an excellent opportunity to start a career with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients' lives!

Regulatory Knowledge:
  • Has practical understanding of relevant HA guidelines, PQS guidelines 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 manager)
  • 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 manager and TRL
  • Submission Support Activities:
  • Coordinate activities required for submission generation and review
  • Ensure all technical regulatory submissions 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
  • Ensure submissions are performed per project timelines or timeless agreed with Health Authorities
  • Ensure all regulatory correspondence and submission-related documents are archived
  • Communication:
  • Effectively communicate with line manager, TRT members and stakeholders to inform of project status and strategy in accordance with defined role
  • Communicates project challenges to line manager in an appropriate and timely manner
  • Communicate internally to facilitate the review and approval of submissions
  • Displays high degree of capability in assigned written and oral presentation

Skills:
  • Able to manage multiple projects independently
  • Able to work in teams in a matrix environment
  • Able to 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.

Education:
  • Bachelor's degree or higher in a relevant scientific discipline
  • Prior experience in CMC Regulatory, Large Molecule, Post Marketed preferred