Location: DC/Maryland

 MUST HAVE PRIOR EXPERIENCE WORKING IN A
 REGULATORY  AFFAIRS DEPARTMENT OF A BIOTECH OR     
PHARMACEUTICAL COMPANY TO BE CONSIDERED FOR
 THIS POSITION.

 Newly created Associate Director, Regulatory Affairs position
with a successful and stable company with marketed products
and an incredible pipeline of products in multiple therapeutic
areas and in all stages of development.

REALLY MAKE A DIFFERENCE:

You will be the global regulatory leader for your early stage
development projects in a high focus therapeutic area for this
organization. You will be working on compounds for under-
served diseases where there are currently no treatments!!

SOME OF THE THINGS YOU WILL BE DOING:

    1.  Lead development of innovative regulatory strategy for all
         phases of drug development for investigational products

    2. Represent Regulatory Affairs at project meetings and other
        governance related meetings, providing guidance to
        Research, Clinical Development and Manufacturing at
        Project Team meetings.

    3.  Interact with responsible departments and lead preparation,
        review, and assembling of the scientific (nonclinical, clinical,
        and manufacturing) and administrative sections of
        submissions to US, national and international regulatory
        agencies.

    4. Plan, coordinate, prepare and execute meetings and
        teleconferences with regulatory agencies.

  WHAT YOU MUST HAVE TO BE CONSIDERED:

  • Minimum of a BS in a scientific discipline
  • A minimum of 6 years experience in Regulatory Affairs.
  • Knowledge of FDA regulations required.  
  • Direct liaison experience with FDA required.  Knowledge of   
     international regulatory guidelines (e.g., ICH), GCP and GMP   
     requirements is desirable.  
  • Ability to work independently with minimal supervision
  • Excellent interpersonal, communication and written skills


  send resumes to:  sue.komers@eliteresourcesolutions.com
Associate Director Regulatory Affairs                            Job # 9172        
Elite Resource Solutions, LLC