Job Description
Job Summary: The Manger 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 manger'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.
- nswers 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
- dvanced 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
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