Regulatory Operations Manager

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve antitumor activity. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T and CAR-NK platforms as readily available treatments for patients with hematologic malignancies and solid tumors.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

Our Regulatory Affairs team is seeking a highly motivated Regulatory Operations Manager.  Reporting to the Senior Director of Regulatory Operations, you will be responsible for assembling, formatting, and publishing regulatory dossiers (e.g., IND, CTA, BLA, MAA) for global registration and lifecycle management submissions (e.g., supplements, amendments, variations) to meet corporate objectives for both ongoing business and new product development. You will independently develop, implement, and maintain processes and operational components of submission production, such as publishing, dispatch, and archiving. This position is hybrid or remote.

Responsibilities:

• Gather information, format, and assemble regulatory submissions, particularly IND Chemistry Manufacturing and Controls (CMC), nonclinical and clinical amendments, as appropriate
• Perform technical editing (i.e., references, internal/external linking, definitions, acronyms, etc.) 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

Qualifications:

• 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

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $130,000 - $155,000 - This represents the present low and high end of the Company’s pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance.
• 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

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

 

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