Beam is seeking a highly energetic, talented and motivated Regulatory co-op to join our growing Regulatory team. The Regulatory Affairs co-op will support the Regulatory Affairs team by performing research for regulatory intelligence, summarizing guidance and maintaining trackers. The candidate will gain experience in navigating real world projects related to health authority interactions and submission processes for investigational products. In addition, there is the opportunity to work with Quality Control on implementing a new methodology to track and trend in-process and release data using statistical analyses.

Responsibilities:

Regulatory Affairs

• Summarize and index relevant CMC guidance documents.
• Develop and maintain trackers for the Regulatory team.
• Research to build the regulatory intelligence platform.
• Create, design, and general upkeep of Regulatory SharePoint Site.
• Create chronology logs for active programs.
• Prepare and review documents for submissions and other administrative tasks.
• Data verification to support submissions.

Qualifications:

• Pursuing a Bachelor's degree in Biotechnology, Bioengineering, Biochemistry, or related field.
• Prior industry internship or academic lab-based research experience is preferred.
• The candidate should have a solid academic foundation in science and laboratory coursework (examples: biology/chemistry/biochemistry, biochemical/bioengineering, microbiology, tissue culture, molecular biology, etc.)
• A team player who is curious, motivated to learn, organized, and has good communication skills
• Note, this role will function within a hybrid (partially remote, partially onsite) working environment, and requires a self-motivated individual.