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RayzeBio Director of Regulatory Affairs - Clinical / NonClinical

RayzeBio Director of Regulatory Affairs - Clinical / NonClinical

Bristol Myers SquibbSan Diego, CA, US
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Director, Regulatory Affairs

We are seeking an experienced and innovative Director in Regulatory Affairs (clinical and nonclinical). This Global Regulatory Lead (GRL) position will report to the Head of Regulatory Affairs and will oversee and / or manage regulatory functions and direct reports within RayzeBio. Responsibility expectations will be commensurate with experience.

Job Responsibilities

  • Global Regulatory Lead for a cutting edge RPT program
  • Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions.
  • Authoring of regulatory documents that are required for regulatory interactions.
  • Keeping up to date in the relevant disease areas, including anticipating changes in standard of care as perceived by regulatory authorities and other key customers.
  • Maintaining an expert knowledge of the relevant regulatory landscape.
  • Maintaining a relationship with and representing the company to regulators.
  • Lead the preparation, authoring and submission of regulatory filings (e.g., pre-IND meeting materials, INDs, IND amendments, CTA / IMPD, annual report, briefing document, iPSP / PIP, safety reports, marketing applications).
  • Lead the preparation for Health Authority Interactions.

Basic Qualifications

  • Bachelor's degree or higher
  • 7 or more years of hands-on regulatory experience
  • Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development and familiarity with radioisotopes such as 68Ga, 177Lu, 225-Ac, 161Tb, F18, Y90, etc.
  • Experience with clinical regulatory strategy in prostate cancer
  • Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced industry environment.

    • Skills

  • Excellent written and verbal communication skills.
  • Highly organized, with the ability to multi-task and handle pressure well
  • Meticulous with detail and precision
  • Ability to think through a project or task of diverse complexity and execute independently from beginning to end
  • Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing
  • Strong communication and interpersonal skills
  • Should be assertive, proactive, professional, and confident
  • Excellent professional ethics and integrity
  • Flexibility to adapt in a cross-functional and dynamic environment

    • Compensation Overview

    San Diego - RayzeBio - CA : $227,418 - $275,577

    The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit careers.bms.com / life-at-bms / . Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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    Director Regulatory • San Diego, CA, US