Posted to MedZilla on 2/22/2020

EPM Scientific

US-NC, CMC Regulatory Director 452431246972-MZ


Director, CMC Regulatory Affairs


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.


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.








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.


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