Location: southern California

       This is a wonderful opportunity for a Director Regulatory
      Affairs CMC for post-approval CMC for large molecules.    
      This position offers:

      GREAT COMPANY (diversified, stable, growing)

         GREAT WEATHER (and beaches and mountains)

             GREAT OPPORTUNITY

     This Director Regulatory Affairs CMC will provide
     leadership within the Global Regulatory Affairs
     Chemistry, Manufacturing, and Controls (CMC)
     organization by actively contributing to and
     managing staff that development and implement
     global regulatory CMC strategies for approved
     biologics. Key day-to-day activities will
     include the preparation of CMC regulatory
     submissions that meet global regulatory
     requirements, attending project teams or
     oversight committees, and representing the
     company during communications and meetings
     with health authorities.

     Requirements:

     MUST HAVE EXPERIENCE WORKING IN A
     REGULATORY AFFAIRS DEPARTMENT IN A CMC
     LEADERSHIP ROLE TO BE CONSIDERED FOR THIS
     DIRECTOR REGULATORY AFFAIRS CMC ROLE.

  • B.S. required in related scientific discipline with a
    minimum of 10 years experience working in a
    Regulatory Affairs department, including at least 5
    years experience managing people. Advanced
    degree will be an advantage.
  • Must have US and global post-approval CMC
    experience for biologics
  • Must have comprehensive understanding and
    applied knowledge of regulatory requirements
    including FDA, EMEA, ICH guidelines and regulations
    as they apply to registration, development and
    approval of investigational products.   
  • Comprehensive knowledge of the drug development
    process and experience in domestic and
    international product registrations (i.e. IND, CTA, BLA,
    NDA, NDS, MAA)

   send resumes to:  sue.komers@eliteresourcesolutions.com
Director Regulatory Affairs  CMC                    Job # 9303    
Elite Resource Solutions, LLC