Senior Regulatory Affairs Consulting Position

Senior Regulatory Affairs Consulting Position

My client is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver disease.  They have partnered with us to fill a newly created long term Sr. Regulatory Consulting position.  In this role you would be working closely with the VP of Regulatory Affairs to lead US regulatory strategy for multiple programs in development.

 

Responsibilities:

  • Serve as key member of Regulatory/QA leadership team
  • Oversee planning, coordination, and preparation for meetings and teleconferences with US regulatory agencies
  • Provide oversight for paper and electronic submissions, as applicable, to support development project plans and timelines for IND, CTAs, NDA, MAA and related submissions, as well as amendments and supplements to these applications and responses to regulatory agency requests.
  • Coordinate collaboration with responsible departments and oversee preparation, review, and collection of documentation for regulatory submissions.
  • Serve as Global regulatory lead for assigned projects as a full member of the research and development team(s)

 

Qualifications:

  • Bachelor’s degree in Biology or Chemistry, advanced degree preferred
  • 15 years of industry knowledge experience (pharma, biotech, CRO).
  • 10+ years of regulatory experience, NDA/MAA filing experience preferred

 

Number of hours worked per week: 40 hours onsite

Length of Assignment: 1 year with the possibility of extension

Position Location: San Diego, CA

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