Regulatory Operations Manager

Boston, MA

Are you ready to join a team committed to making a meaningful impact through precision medicine? By joining Kura, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we hold precision medicine to a high standard, applying cutting-edge science to create a more personalized approach in the treatment of cancer. We’ve changed the paradigm and improved the science of cancer treatment. We strive to cultivate a diverse and talented professional culture driven to develop therapies and solutions that are as unique as all of us.

As we continue to build a leading biotech organization with a strong culture, relentless execution, and a patient-focused mindset, Kura is planning to grow another 25% this year. To that end, we’re looking for our next innovator to join and help make our vision a reality. To take smart risks in pursuing novel areas of drug research and development and have fun along the way.

To succeed at Kura, you need to have a demonstrated reputation for putting the patient first and foremost, and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

Regulatory Operations Manager 

Reporting to the Sr. Director, Regulatory Affairs, the Regulatory Operations Manager is responsible for operational aspects of regulatory submissions and supports regulatory systems. This role interfaces with external publishing vendor(s) for the preparation of submissions to global health authorities, ensuring that all submissions are compliant, of the highest quality, and submitted in a timely fashion according to established timelines. The position also supports the compilation, archiving, and tracking of regulatory submissions and health authority correspondence, as well as the management and implementation of regulatory systems and tools.

The core duties of the Regulatory Operations Manager are delineated below.

As opportunities permit, the candidate may provide ongoing support to regulatory intelligence surveillance and work closely with senior members of the regulatory affairs team on project-related tasks.

ESSENTIAL JOB FUNCTIONS:

  • Create and manage submission plans in conjunction with Regulatory and other cross-functional colleagues in support of timely and compliant submissions.
  • Manage electronic submission publishing activities with third-party vendors and perform quality control (QC) review.
  • Provide advanced editing/formatting support (document-level publishing) to ensure submission documents are accurate and meet technical formatting standards.
  • Provide in-house technical expertise relating to document-level publishing (advanced editing/formatting), electronic Common Technical Document (eCTD) granularity and lifecycle management, utilization of content templates, eCTD standards, and requirements.
  • Track and archive submissions and health authority correspondence; manage regulatory records and databases.
  • Serve as system owner for regulatory information tools and systems (e.g., eCTD publishing tools, electronic document management system (EDMS), regulatory information management (RIM) system, library system, and electronic templates).
  • Maintain expert knowledge of electronic submission and computerized system validation standards.
  • Ensure compliance with all applicable laws, regulations, and policies.
  • Provide input into process development and refinement.
  • Present project and professional information to appropriate individuals in a concise, clear, and objective manner, and with grammatical accuracy.

JOB SPECIFICATIONS:

  • BA degree in a science or related field.
  • Ideally 5 years in a life sciences environment, with 2-5 years of relevant experience within the regulatory operations discipline.
  • Knowledge of US and international regulatory requirements.
  • Extensive knowledge of and experience with Microsoft Office Suite, Adobe Acrobat and plug-in tools, eCTD content templates (eg, StartingPoint), Regulatory Document and Information tools, and EDMS and eCTD publishing systems.
  • Advanced understanding of relevant health agency eCTD requirements, formatting and submission standards, software validation concepts, and publishing best practices.
  • Familiarity with dossier content requirements for global regulatory health authority submissions as well as ICH regulations and guidelines.
  • Must be a dedicated self-starter with the initiative and ability to take ownership of and achieve specific tasks.
  • Must have strong communication, time management, and organization skills.
  • Must be highly detail-oriented with the ability to multi-task and shift priorities quickly under tight deadlines with minimal oversight.
  • Demonstrates a positive “can do” attitude and fosters collaborative internal and external relationships.

THE KURA PACKAGE

  • Career advancement/ development opportunities
  • Competitive comp package
  • Bonus
  • 401K + employer contributions
  • Generous stock options
  • ESPP Plan
  • 20 days of PTO to start
  • 14 Holidays + 3 Floater Holidays (Including Winter Break), Summer Hours
  • Generous benefits package with a variety of plans available with a substantial employer match
  • Paid Paternity/Maternity Leave
  • In-Office catered lunches
  • Home Office Setup
  • Cell Phone and Wellness Stipend
  • Commuter Stipend (Boston Office)
  • Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company’s diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology was founded in 2014 and has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor currently being evaluated in patients with certain head and neck cancers that carry HRAS mutations. KO-539 is an oral investigational drug candidate we are developing for the treatment of genetically defined AML patients with high unmet needs, currently in a Phase 1/2A clinical trial. KO-539 blocks the interaction of two proteins called menin and MLL that, together, are critically important for survival, growth, and proliferation of certain kinds of leukemia cells.

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. To apply, please submit your resume to careers@kuraoncology.com