Job Details

  • Title: Regulatory Affairs Coordinator
  • Code: RCI-8926
  • Location: Thousand Oaks California (CA) 91320
  • Posted Date: 07/27/2021
  • Duration: 36 Months
Talk to our Recruiter

  Job Description

Description:

 

Can be either or remote.

 

  • Prefer regulatory operations experience (Veeva- preferred)
  • Must be able to use Microsoft Associate
  • Detail oriented skill set
  • Able to perform multiple tasks/functions

 

Regulatory operations:

  • Assist Regional Regulatory Representative to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
  • Create and maintain product regulatory history documents through Veeva and appropriately archive all regulatory documents and agency communications.
  • Ensure compliance with submissions to regulatory agencies
  • Coordinate QC of regulatory documentation (e.g. in Veeva)

 

Top 3 Must Have Skill Sets:

  • Prefer regulatory operations experience (especially Veeva if available)
  • Detail oriented skill set
  • Able to perform multiple tasks/functions

Day to Day Responsibilities:

  • Maintain Regulatory document management and tracking systems.
  • Create/archive Clinical Trial and Marketing Application submissions/Health Authority
    correspondence
  • Point of contact between Regulatory Representatives/CMC and publishing teams.
  • Ensuring Regulatory compliance with SOPs and Regulatory authorities
  • Provide training, mentoring and support to RDA team members and other functional areas, including vendors.
  • Collaboration with external partners/outsourced CROs
  • Run 1572 forms for FDA submission.

Employee Value Proposition:

 

  • Team atmosphere, great team to work with. Lots of exposure to biotech/pharma. Exposure to a highly communicative team. On the job training and development.