Job Details

  • Title: Regulatory Affairs Associate
  • Code: RCI-08676
  • Location: Foster City California (CA) 94404
  • Posted Date: 07/31/2020
  • Duration: 12 Months
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  Job Description

  • Responsible for preparing routine regulatory submissions which require some interactions with others in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures
  • May have responsibility for preparing submissions, which may include, but are not limited to: safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations
  • May provide input to the development of labeling and submit labeling changes, and drug listing
  • Participate in group meetings and provide tactical approaches to addressing problems of moderate complexity
  • Responsible with manager for development and acquisition of required regulatory skills and knowledge
  • May contribute to local process improvements, which have an impact on the working of the Regulatory Affairs function or other departments
Qualifications
  • Excellent organization skills and ability to work on a number of projects with tight timelines is required
  • Excellent verbal and written communication skills and interpersonal skills are required
  • Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories
  • Act as a resource on limited topics within the department
  • Work is performed under the general supervision of more senior Regulatory Affairs professionals
  • Work is reviewed for soundness of judgment and overall adequacy