B.S. or B.A. degree required; life sciences or engineering preferred
M.D. or Ph.D. is preferred
8+ years in human medical product regulatory affairs
Expertise in FDA regulations and clinical trials
Strong communication and influencing skills
Proficient in Microsoft Office
Analytical problem-solver with attention to detail
Responsibilities
Attend client meetings for strategic regulatory guidance
Provide expertise in regulatory strategy and study design
Draft and review FDA meeting request packages
Contribute to writing and organizing regulatory applications
Mentor junior regulatory staff
Create educational materials for regulatory workshops
Support ARMI | BioFabUSA project initiatives
Benefits
Opportunities for professional development and continuing education
Mentorship from senior regulatory professionals
Collaborative work environment with a focus on innovative solutions
Engagement with industry events and workshops
Involvement in a mission-driven organization focused on scientific integrity
Full Job Description
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
