Job Title: CMC Regulatory Specialist
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The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices. This includes providing oversight in method development and validation, compendial method verification and transfer, specification/acceptance criterion development, stability testing, out of specification (OOS) investigation, post-approval manufacturing changes, verification of active pharmaceutical ingredient (API) components to recognized compendial standards, and API vendor qualifications and audit.
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Responsibilities:
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* Maintain a high level of expertise in FDA, US Pharmacopeia, and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics.
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* Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions.
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* Support submissions pertinent to CMC for global regulators.
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* Technically review data and reports for accuracy and consistency with regulator's expectations.
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* Collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification, and support audits of same.
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* Lead or participate in engineering projects as a subject matter expert within the field of CMC and test method development.
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* Provide input on new product introduction and assessing proposed manufacturing changes.
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* Support the Investigation / Root Cause Analysis of OOS API results.
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* Collaborate with other Post Market / Manufacturing Engineering Teams to ensure effective completion of all activities associated with Post Market Engineering projects / objectives.
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Qualifications:
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* Bachelor's degree, Master's or PhD is required, preferably in engineering/science or a related field.
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* Minimum of 3 years' relevant experience with CMC.
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* Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards.
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* Familiarity with FDA, US Pharmacopeia and/or European Pharmacopeia and ICH CMC regulatory topics.
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* Proven analytical and problem-solving skills.
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* Strong interpersonal skills and ability to communicate across functions.
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* Familiarity with statistical methods, analysis, and interpretation.
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* Ability to work on multiple projects, organize, and prioritize within time constraints.
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* Familiarity with Microsoft Office software.
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* High self-motivation.
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* Willingsness and availability to travel on company business.
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