Required Qualifications, Education and Experience: 

● Degree in a Scientific Discipline (Graduate Degree preferred) 

● RAC (Regulatory Affairs Certification) from RAPS, preferred 

● Minimum 7+ years pharmaceutical Regulatory Affairs experience (with combination product, military, clinical and CMC experience) 

● Experience with administration and drug delivery systems (auto-injectors) 

● Excellent knowledge and understanding of FDA/21 CFR Part 4 (combination products)/ISO 13485/ICH/DEA regulations and relevant guidance and standards (ISO 11608-1) 

● Minimum US Class II sterile device experience and in-depth knowledge of US FDA regulations (Title 21 CFR). EU Class IIa sterile device experience and knowledge of EU MDR 2017/745 preferred, not required. 

● History of successful US 510(k) device submissions (EU technical files experience preferred) 

● Advanced knowledge of 21 CFR 820/ISO 13485-2016/ISO 14971/MIL 810h 

● Experience with regulatory Inspections, PAIs and Field Actions 

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● Solid knowledge of eCTD Quality sections and regulatory submissions experience 

 

Areas of Responsibility: 

● 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. 

● Review and revise existing strategy. 

● Answer 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. 

● Track, document, and communicate progress of regulatory submissions and approvals. 

● Order, track and process combination product and CMC-related regulatory submission documentation (e.g. certificates, declarations, sample requests and COAs/COCs). 

● Partner with the Project Manager and CFO on regulatory milestone timing that supports DoD contract deliverables and financial forecast; own IND management and maintenance for the combination product pipeline; coordinate agency meeting timing and pre-submission cadence with the executive team. 

● Collaborate and routinely interface 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. 

 

● 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. 

 

Skills Required 

● Candidates should thrive in a fast-paced, startup-like environment where the expectation is to handle both strategic and operational tasks. You must be comfortable working with minimal support and be willing to pivot as priorities shift. 

● Exceptional verbal and written communication skills, with the ability to comprehend, organize and convey complex scientific/clinical information accurately and maintain a high level of detail and accuracy under strict deadlines. 

● Ability to manage multiple projects in a start-up environment. 

● Ability to work independently, guided by procedures with minimum support. 

● Maintains the highest ethical standards, including a commitment to company values, professionalism, and behaviors. 

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● Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures 

● Authorized to legally work in the United States without visa sponsorship. 

● Ability to perform other duties as assigned by management. 

 

RAC (Regulatory Affairs Certification) from RAPS, preferred