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.
Please visit our website at www.epmscientific.com