Regulatory Affairs Specialist

About This Role

Serve as a key resource providing technical expertise and regulatory guidance to the research community, focusing on pre-market regulatory submissions for drugs, biologics, and devices. Ensure compliance with FDA, IRB, and IBC regulations while collaborating with various internal groups.

Responsibilities

• Maintain comprehensive knowledge of regulatory standards and guidelines for drugs, biologics, and device products
• Review, evaluate, and advise on submissions in coordination with PIs/research teams for compliance with regulatory standards
• Collaborate with investigators during study development to ensure appropriate regulatory safeguards are included
• Participate in Regulatory Agency meetings in a regulatory support function and compile regulatory documents
• Provide regulatory advice to Manne Research Institute sponsor-investigators and their research teams
• Develop and maintain regulatory trackers and databases to monitor submission timelines and communicate updates
• Support the IRB and Quality Assurance team by reviewing or auditing regulated research studies for regulatory issues
• Identify training opportunities and disseminate information to the research community through education initiatives
• Assist with new and ongoing research projects related to regulatory issues with the objective to publish findings

Requirements

• Bachelor’s degree in a related field
• 5+ years substantive experience in research or a regulated field
• 2+ years experience in regulatory affairs, clinical research, or a related area within pharmaceutical, biotech, or medical device industries
• Familiarity with FDA submission processes and related regulatory requirements
• Strong organizational, analytical, and project management skills
• Excellent communication skills for interacting with regulatory agencies and cross-functional teams
• Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record (EPIC))

Qualifications

• Bachelor’s degree in a related field
• Minimum of 5 years substantive experience in research or a regulated field with at least two years of experience in regulatory affairs, clinical research, or a related area within the pharmaceutical, biotech, or medical device industries.

Nice to Have

• Master’s or PhD degree in Biology, Chemistry or Life Sciences or equivalent (e.g. MD or PharmD)
• Industry experience
• Certification or eligibility to sit for Certification Exam in relevant area

Skills

* Required skills

Benefits

Certifications