RayzeBio Director of Regulatory Affairs - Clinical/NonClinical

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Job Title: Director, Regulatory Affairs 

Department: Regulatory Affairs 

Location: San Diego 

Job Description 

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. This role has the option for Remote.

Job Responsibilities 

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

• 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 

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 https://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.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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