Regulatory Associate IV

South San Francisco, CA 94080

Posted: 01/07/2019 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 5378

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties: 

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
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