Caribou Biosciences is hiring a
Regulatory Operations Manager

Summary

The job description is for a Regulatory Operations Manager at Caribou Biosciences, responsible for assembling and formatting regulatory submissions, maintaining processes and operational components of submission production, improving regulatory operations practices, and ensuring adherence to established business standards and global regulatory requirements. The position requires a Bachelor's degree in a related discipline with a minimum of 5 years of regulatory experience in the pharmaceutical industry or a Master's degree with a minimum of 4 years of experience.

Requirements

• Bachelor’s degree in related discipline and a minimum of 5 years of regulatory experience in pharmaceutical industry; Master’s degree in related discipline and a minimum of 4 years of regulatory experience in pharmaceutical industry
• Proficiency using Adobe Acrobat Professional and eCTD building/compilation software
• Advanced proficiency in MS Office applications, including expert working knowledge of Word templates, styles, and macros

Responsibilities

• Gather information, format, and assemble regulatory submissions, particularly IND Chemistry Manufacturing and Controls (CMC), nonclinical and clinical amendments, as appropriate
• Perform technical editing and document formatting for submission readiness; provide final approved documents and submission preparation
• Facilitate the internal review and approval process for regulatory submissions
• Perform copyediting, formatting, publishing, and quality control checking of regulatory documents for submission to ensure that they meet applicable regulations and Caribou’s style and publishing guidelines
• Continuously improve regulatory operations practices and ensure adherence to established business standards and global regulatory requirements
• Manage and collaborate with eCTD publishing vendor, including managing e-publishing vendor and training other employees on QC link check activities
• For complex submissions, track and manage workflow timelines internally and with publishing vendor to ensure that corporate milestone goals are met
• Maintain regular communication channel to keep teams apprised of the status of submission publication activities
• Produce high quality and timely submissions to global Regulatory Health Authorities
• Possess a clear understanding of eCTD submission requirements and develop a good working knowledge of all tools and systems used in support of publishing processes
• Maintain the regulatory files in accordance with established requirements and enable for quick search (e.g., searchable PDF) and retrieval
• Review regulatory agency publications, such as the Federal Register, for relevant information covering new governing policies and guidelines and distribute information to company personnel
• Train and mentor other employees to promote professional growth and the development of high-quality published content
• Participate in the development of standard operating procedures
• Lead the effort in selection, implementation, and execution of a regulatory information management system (RIMS), as required

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $130,000 - $155,000
• Generous paid vacation time, in addition to company-observed holidays and floating holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program