Senior Regulatory Affairs Specialist

Job Description

Job Description

Overview The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact. The Impact That You Will MakeRegulatory Affairs is critical to our success. In this role, you will contribute to a strong Regulatory team, devising robust regulatory strategies for ARMI members and internal projects, while ensuring compliance to federal regulations. Products include complex biologics, devices, and combination products, with many in the preclinical and clinical spaces.  Your RoleAttend meetings and teleconferences with clients seeking strategic regulatory guidanceProvide expertise related to regulatory strategy, preclinical and clinical study design, CMC, and other topicsDraft and review FDA meeting request packages; attend FDA teleconferencesContribute to the planning, development, organization, writing, and editing of regulatory applications for BioFabConsulting members/clientsProvide guidance and mentorship to more junior regulatory staffCreate original regulatory education materials, such as workshop content and web pagesProvide input and assistance on ARMI | BioFabUSA projects in the technical, education and workforce development, and membership areas on an as-needed basisContinually bolster personal knowledge by studying trends and developments in regulatory affairs, participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizationsAttend events, workshops, and meetings organized by ARMI | BioFabUSA or by ARMI members Your Skills and ExperiencesB.S. or B.A. degree required; degree in life sciences or engineering is required. M.D., or Ph.D. is preferredMinimum of 8 years of direct work experience in human medical product regulatory affairs; experience with clinical trials of drugs or biologics is preferredThorough knowledge of U.S. FDA medical product regulations, current industry practices, and experience with interpretation and application of said regulations and practicesAbility to influence colleagues, clients, and Institute members at all levels in the organizationExceptional written and verbal communication skillsProficient with Microsoft software productsAbility to multi-task, meet deadlines, and set prioritiesAbility to work independently and thrive in a fast-paced, rapidly changing environmentCollaborative attitude, sense of curiosity, and eagerness to impact positive changeCommitment to quality, scientific integrity, and company missionStrong analytical and proactive problem-solving skills with a strong attention to detailAbility to work independently and manage competing prioritiesBy applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.