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    Regulatory Operations Manager - Berkeley, United States - Caribou Biosciences

    Caribou Biosciences
    Caribou Biosciences Berkeley, United States

    4 days ago

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    Description


    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 appropriatePerform technical editing (i.e., references, internal/external linking, definitions, acronyms, etc.) and document formatting for submission readiness; provide final approved documents and submission preparationFacilitate the internal review and approval process for regulatory submissionsPerform 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 guidelinesContinuously improve regulatory operations practices and ensure adherence to established business standards and global regulatory requirementsManage and collaborate with eCTD publishing vendor, including managing e-publishing vendor and training other employees on QC link check activitiesFor complex submissions, track and manage workflow timelines internally and with publishing vendor to ensure that corporate milestone goals are metMaintain regular communication channel to keep teams apprised of the status of submission publication activitiesProduce high quality and timely submissions to global Regulatory Health AuthoritiesPossess a clear understanding of eCTD submission requirements and develop a good working knowledge of all tools and systems used in support of publishing processesMaintain the regulatory files in accordance with established requirements and enable for quick search (e.g.

    , searchable PDF) and retrievalReview regulatory agency publications, such as the Federal Register, for relevant information covering new governing policies and guidelines and distribute information to company personnelTrain and mentor other employees to promote professional growth and the development of high-quality published contentParticipate in the development of standard operating proceduresLead the effort in selection, implementation, and execution of a regulatory information management system (RIMS), as requiredQualifications: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 industryProficiency using Adobe Acrobat Professional and eCTD building/compilation softwareAdvanced proficiency in MS Office applications, including expert working knowledge of Word templates, styles, and macrosCaribou 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 holidaysExcellent medical, dental, and vision insurance401(k) retirement savings plan, which includes matching employer contributionsEmployee stock purchase plan (ESPP)Tuition reimbursement programThe 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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