Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Advanced Regenerative Manufacturing Institute Inc Manchester, NH Job Details Full-time 1 day ago Qualifications Technical editing FDA submissions Research design Medical writing Doctor of Medicine Customer communication Clinical development Bachelor of Science Content writing Drug regulation Educational material preparation Research project design 8 years Analysis skills Bachelor's degree in engineering Doctor of Philosophy Task prioritization Industry trends Mentoring Organizational skills Chemistry, manufacturing & controls Regulatory submission editing and review Biomedical regulatory compliance Communication with regulatory authorities for clinical trials Productivity software Senior level Bachelor of Arts Content review Communication skills Workforce development Full 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 Make Senior Regulatory Affairs Consultants are 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 Role Attend meetings and teleconferences with clients seeking strategic regulatory guidance Provide expertise related to regulatory strategy, preclinical and clinical study design, CMC, and other topics Draft and review FDA meeting request packages; attend FDA teleconferences Contribute to the planning, development, organization, writing, and editing of regulatory applications for BioFabConsulting members/clients Provide guidance and mentorship to more junior regulatory staff Create original regulatory education materials, such as workshop content and web pages Provide input and assistance on ARMI | BioFabUSA projects in the technical, education and workforce development, and membership areas on an as-needed basis Continually 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 organizations Attend events, workshops, and meetings organized by ARMI | BioFabUSA or by ARMI members Your Skills and Experiences B.S. or B.A. degree required; degree in life sciences or engineering is required. M.D., or Ph.D. is preferred Minimum of 8 years of direct work experience in human medical product regulatory affairs; experience with clinical trials of drugs or biologics is preferred Thorough knowledge of

U.S. FDA

medical product regulations, current industry practices, and experience with interpretation and application of said regulations and practices Ability to influence colleagues, clients, and Institute members at all levels in the organization Exceptional written and verbal communication skills Proficient with Microsoft software products Ability to multi-task, meet deadlines, and set priorities Ability to work independently and thrive in a fast-paced, rapidly changing environment Collaborative attitude, sense of curiosity, and eagerness to impact positive change Commitment to quality, scientific integrity, and company mission Strong analytical and proactive problem-solving skills with a strong attention to detail Ability to work independently and manage competing priorities