Manager of Regulatory Affairs
The Director 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). As a ‘player-coach,’ the Director of Regulatory Affairs will lead regulatory strategy, build the company’s regulatory function, and personally handle critical submissions and stakeholder communications.
PLACE OF WORK: Remote
REPORTS TO: Chief Executive Officer
HOURS OF WORK: Consultant to Full-time Hire
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.
● 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.
● Internal team not available but consultants may be available depending on budget constraints.
● 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.
● Authorized to legally work in the United States without visa sponsorship.
● Ability to perform other duties as assigned by management.
Required Qualifications, Education and Experience:
● Degree in a Scientific Discipline (Graduate Degree preferred)
● Minimum 15+ 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/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
Physical Requirements / Work Environment
● Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
● The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, or other electronic device; and extensive reading.
● The worker is not substantially exposed to adverse environmental conditions.
Rx Bandz is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.