Regulatory Affairs Manager Drug-Device Combinations

Company

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Rx Bandz is a patient-centric company delivering the next generation of hydraulic drug delivery auto-injector platform and new emergency medications. We are advancing the world of health by improving patient quality of life, enabling patients to have their life-saving medication on hand wherever and whenever needed. We are a highly cross-functional group of extremely passionate employees; every perspective is encouraged. We see our presence in virtually every country around the world to address some of the most challenging global health issues impacting patient access to injectable medication.

Job Summary: 

The Regulatory Affairs Manager is responsible for managing the regulatory and scientific aspects of projects/products including the preparation and submission of correspondence and applications to regulatory agencies (CDRH, CDER, and or CBER). As a 'player-coach,' the Regulatory Affairs Manager will lead regulatory strategy, build the company's regulatory function, and personally handle critical submissions and stakeholder communications. This role is expected to run approximately 80% hands-on submissions, agency interactions, and stakeholder work, with the remaining 20% on function building, mentorship, and regulatory strategy. Salary starts at $95,000 depending on experience.

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

? 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. xhyhwjd

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