Senior Regulatory Affairs Specialist

The Impact That You Will Make

The Senior Regulatory Affairs Consultants play a critical role in advancing ARMI's mission. They devise robust regulatory strategies for ARMI members and internal projects, focusing on complex biologics, devices, and combination products in various stages from preclinical to clinical.

Your Role

• Attend meetings and teleconferences with clients for strategic regulatory guidance
• Provide expertise in regulatory strategy, preclinical and clinical study design, CMC, and other relevant topics
• Draft and review FDA meeting request packages; attend FDA teleconferences
• Contribute to the planning, development, organization, writing, and editing of regulatory applications for ARMI members/clients
• Provide guidance and mentorship to more junior regulatory staff
• Create original regulatory education materials, such as workshop content and web pages
• Offer input and assistance on ARMI | BioFabUSA projects in technical, education, workforce development, and membership areas as needed
• Bolster personal knowledge by studying trends and developments in regulatory affairs, participating in educational opportunities, reading professional publications, maintaining personal networks, and engaging with professional organizations
• Attend events, workshops, and meetings organized by ARMI | BioFabUSA or by ARMI members

Your Skills and Experiences

• Bachelor’s or Bachelor’s degree required; a degree in life sciences or engineering is preferred
• 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

Qualifications

Background check is required for any offer of employment.