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Location: Remote

Job Summary

We are seeking an experienced and motivated Senior Manager in Regulatory Affairs. This position will report to the Sr. Director of Regulatory Affairs and will oversee and/or manage clinical and nonclinical regulatory functions within RayzeBio. Responsibility expectations will be commensurate with experience. This is a remote-based role.

Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

Serves as Global Regulatory Lead (GRL)Regulatory strategy, including timing and nature of global regulatory interactions.US Labeling Lead and Company Core Data Sheet (CCDS Lead); lead Label Working Group (LWG) to execute strategy in alignment with company and program goals.Generation 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 and submission of regulatory filings (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications).Lead the preparation for Health Authority Interactions.

Education And Experience

Bachelor’s degree or higher5 or more years of hands-on regulatory experience, experience of clinical regulatory strategy in oncology would be a distinct advantage.Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.

Skills And Qualifications

Excellent written and verbal communication skills.Highly organized, with the ability to multi-task and handle pressure wellMeticulous with detail and precisionAbility to think through a project or task of diverse complexity and execute independently from beginning to endFully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencingStrong communication and interpersonal skillsShould be assertive, proactive, professional, and confidentExcellent professional ethics and integrityFlexibility to adapt in a cross-functional and dynamic environment

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment

The noise level in the work environment is usually moderate.

The starting compensation for this job is a range from $145,495-$196,846 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

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