Associate Director, Global Regulatory CMC Biologics

Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products. Be accountable for the delivery of all regulatory milestones through product development.  Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory CMC requirements and identification of potential risks. Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems. Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed. Conduct all activities with an unwavering focus on compliance. Technical Skills: Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.  Strong listening skills. Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.   Leadership Skills: Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, interpersonal and negotiating skills. Qualifications Education Minimum Requirement:  B.S. in a biological science, engineering, or a related field (advanced degree preferred).   Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry. Required Experience and Skills:   At least ten (10) years of relevant experience , including biological research; manufacturing, testing, or licensure of biological products; or related fields. 6 years for Ph.D. degree. The candidate must be proficient in English; additional language skills are a plus. The candidate may be required to travel on a periodic basis. Requisition ID: REG004025
Salary Range: NA
Minimum Qualification
11 - 15 years

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