Regulatory Associate I

South San Francisco, CA 94080 | Contract

Post Date: 07/10/2018 Job ID: 4467 Industry: Regulatory Affairs & Compliance

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, 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

 

 

Skills:

  • 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

 

Education:

  • Minimum of 2 years of Regulatory experience.
  • Bachelor's degree or higher in a relevant scientific discipline.
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