Katalyst CRO
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Regulatory Affairs Manager
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Katalyst CRO The Manager of Regulatory Affairs is responsible for managing the regulatory and scientific aspects of projects/products including the preparation and submission of correspondence and applications to regulatory agencies (CDHR, CDER, and or CBER). The manager's role will span high-level strategy and day-to-day execution and needs to be an agile, cross-functional leader able to navigate resource constraints. Responsibilities Identifies, obtains, compiles, authors and reviews regulatory documents concerning combination products and CMC-related issues that are needed for FDA submissions including IND and NDA/BLA submissions, NDA supplements and briefing packages for agency meetings and regional approvals. Answers Information Requests (IR) generated during submission review cycles. Development of regulatory strategies, timelines and plans for the combination product development platform. Preparation of annual reports and keep other annual updates or reports current. Review and assess the regulatory impact of routine proposed manufacturing and product related changes, non-conformance events and other GMP related documents; research topics when requested. Tracks, documents, and communicates progress of regulatory submissions and approvals. Orders, tracks and process combination product and CMC-related regulatory submission documentation (e.g. certificates, declarations, sample requests and COAs/COCs). Collaborates and routinely interfaces cross-functionally with internal and external stakeholders (e.g. key suppliers, engineering, drug development, and quality) in the context of major manufacturing initiatives and new product introductions. Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures. Evaluate and communicate impact of relevant regional regulations, local and national compliance, guidance and current regulatory environment. Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change. Other duties as assigned. Requirements Bachelor's or master's degree in life sciences, health informatics, computer science, or related field. Advanced degree preferred. Minimum 10+ years pharmaceutical Regulatory Affairs experience (with combination product, clinical and CMC experience) Experience with administration and drug delivery systems (auto-injectors) Excellent knowledge and understanding of FDA/ISO 13485/ICH/DEA regulations and relevant guidance and standards (ISO 11608-1) Minimum US Class II and EU Class Ia sterile device experience and in-depth knowledge of US FDA regulations (Title 21 CFR) and EU medical device regulations MDR 2017/745 History of successful US 510(k) device and EU technical files submissions Advanced knowledge of 21 CFR 820/ISO 13485-2016/ISO 14971/MIL 810h Experience with regulatory Inspections, PAIs and Field Actions Solid knowledge of eCTD Quality sections and regulatory submissions experience Seniority level : Mid-Senior level Employment type : Contract Job function : Regulatory Affairs Industries : Pharmaceutical Manufacturing
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Regulatory Affairs Manager
role at
Katalyst CRO The Manager of Regulatory Affairs is responsible for managing the regulatory and scientific aspects of projects/products including the preparation and submission of correspondence and applications to regulatory agencies (CDHR, CDER, and or CBER). The manager's role will span high-level strategy and day-to-day execution and needs to be an agile, cross-functional leader able to navigate resource constraints. Responsibilities Identifies, obtains, compiles, authors and reviews regulatory documents concerning combination products and CMC-related issues that are needed for FDA submissions including IND and NDA/BLA submissions, NDA supplements and briefing packages for agency meetings and regional approvals. Answers Information Requests (IR) generated during submission review cycles. Development of regulatory strategies, timelines and plans for the combination product development platform. Preparation of annual reports and keep other annual updates or reports current. Review and assess the regulatory impact of routine proposed manufacturing and product related changes, non-conformance events and other GMP related documents; research topics when requested. Tracks, documents, and communicates progress of regulatory submissions and approvals. Orders, tracks and process combination product and CMC-related regulatory submission documentation (e.g. certificates, declarations, sample requests and COAs/COCs). Collaborates and routinely interfaces cross-functionally with internal and external stakeholders (e.g. key suppliers, engineering, drug development, and quality) in the context of major manufacturing initiatives and new product introductions. Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures. Evaluate and communicate impact of relevant regional regulations, local and national compliance, guidance and current regulatory environment. Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change. Other duties as assigned. Requirements Bachelor's or master's degree in life sciences, health informatics, computer science, or related field. Advanced degree preferred. Minimum 10+ years pharmaceutical Regulatory Affairs experience (with combination product, clinical and CMC experience) Experience with administration and drug delivery systems (auto-injectors) Excellent knowledge and understanding of FDA/ISO 13485/ICH/DEA regulations and relevant guidance and standards (ISO 11608-1) Minimum US Class II and EU Class Ia sterile device experience and in-depth knowledge of US FDA regulations (Title 21 CFR) and EU medical device regulations MDR 2017/745 History of successful US 510(k) device and EU technical files submissions Advanced knowledge of 21 CFR 820/ISO 13485-2016/ISO 14971/MIL 810h Experience with regulatory Inspections, PAIs and Field Actions Solid knowledge of eCTD Quality sections and regulatory submissions experience Seniority level : Mid-Senior level Employment type : Contract Job function : Regulatory Affairs Industries : Pharmaceutical Manufacturing
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