Senior Regulatory Affairs Specialist

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

Regulatory Affairs is critical to our 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

By applying I understand that any offer of employment is contingent upon the successful completion of a background check in accordance with applicable laws.

Required Experience:

Senior IC