Regulatory Publisher/Coordinator

170 - Regulatory Affairs · Berkeley, California
Department 170 - Regulatory Affairs
Employment Type Full-Time
Minimum Experience Mid-level

Caribou Biosciences is a clinical-stage biopharmaceutical company founded in 2011 by pioneers in CRISPR genome editing and headquartered in Berkeley, California. The company’s mission is to develop innovative, transformative therapies for patients with devastating diseases through novel genome editing. Caribou leverages its proprietary technologies to develop a wholly owned pipeline of genome-edited, off-the-shelf immune cell therapies, including CAR-Ts and CAR-NKs, for the treatment of multiple different types of cancer. Caribou believes that advanced genome editing is necessary to develop sophisticated cell therapies to treat a variety of malignancies.

 

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, their contributions are recognized, and their needs are met.

 

The Regulatory Publisher / Coordinator is responsible for assembling, formatting, and publishing of 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. Independently develop, implement, and maintain processes and operational components of submission production, such as publishing, dispatch, and archiving. The position level is dependent on experience and qualifications.

In this role, the candidate will be responsible for:

 

Duties and Responsibilities:

  • Gather information, format, and assemble regulatory submissions, particularly IND Chemistry, Manufacturing and Controls (CMC), nonclinical and clinical amendments, as appropriate.
  • Under limited supervision, perform copyediting, formatting, publishing, and quality control checking of regulatory documents for submission to ensure that they meet applicable regulations, Caribou’s style and publishing guidelines. 
  • Seeks to continuously improve regulatory operations practices, ensures adherence to established business standards and global regulatory requirements. 
  • Maintain regular communication channel to keep teams apprised of the status of submission publication activities. 
  • Accountability for 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 available to enable for quick search (e.g., searchable PDF) and retrieval process. 
  • Review regulatory agency publications, such as the Federal Register, for relevant information covering new governing policies and guidelines for distribution to company personnel.


Candidate must possess:

  • Bachelor’s degree in relevant discipline, or equivalent work experience / industry regulatory experience. Minimum 3 years of related technical and/or 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 including stock options and employee stock purchase program
  • Generous paid vacation time in addition to Company-observed holidays and floating holidays
  • Excellent medical, dental, and vision insurance
  • 401(k) retirement savings plan including matching employer contributions
  • Tuition reimbursement program

 

Caribou is an equal opportunity employer and does not discriminate on the basis of 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. 

 

Caribou is on Twitter. Follow the Company @CaribouBio.


 

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  • Location
    Berkeley, California
  • Department
    170 - Regulatory Affairs
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level