Posted to MedZilla on 4/24/2017


Phaidon International

US-NC, CMC Regulatory Director 452431246972-MZ


 
 

Director, CMC Regulatory Affairs


$140,000-200,000


This is an exciting position to lead a team within the CMC Pharmaceuticals Regulatory Affairs for one of the world’s largest and most forward-thinking Animal-Health Companies in the world. This position will allow the incumbent to provide leadership to an establish CMC team for New Products.


Responsibilities:


o Develop strategy, incorporate new systems and leadership to support new CMC filings; active ingredients, new formulations, dosage presentations and production processes; manufacturing or QA changes; and product that meet the needs of Health Authorities and business objectives.


o Lead CMC team within Regulatory Affairs, Analytical R&D, Formulation Development, and Industrial Operations in support of products in development and through life cycle.


o Become internal and external CMC New Products Expert


o Manages and ensures CMC involvement in our company, Committees, project teams, and task forces.   


 


o Ensures appropriate knowledge of new technologies, processes and systems within the function.


 


o Manage allocation of resources to ensure business and project timelines and budget targets are met.


 


o Influence and manage the external regulatory environment as it pertains to CMC.


 


o Manage and hire direct reports


 


o Provide support for functional excellence.


 


 


 


 


Qualifications


 


 


Knowledge and skills:


 


 o Advanced Degree (Ph.D., Pharmacist or equivalent) with five or more years technical experience in the pharmaceutical industry dealing with CMC regulatory affairs responsibilities.


 


o 3-5 years leadership and management of direct report experience.


 


o Record of achievement of timely regulatory approvals globally, life cycle management and demonstrated success dealing with regulatory authorities.


 


o Comprehensive knowledge of scientific, technical, and/or leadership principles plus broad specialized experience with demonstrated and consistent successful performance.


 


o Exceptional written and verbal communication skills.


 


Please visit our website at www.phaidoninternational.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.