Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals We are seeking an experienced and motivated Sr. Director in Regulatory Affairs - CMC. This position will report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions and direct report(s) within RayzeBio. Responsibility expectations will be commensurate with experience. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Responsible for working with the CMC teams to guide the CMC global regulatory strategy for RayzeBio radiopharmaceuticals leading to successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), Drug Master Files (DMFs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions.

Participate in development and execution of global CMC regulatory strategies and development of cold kits and/or diagnostics.

Responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions (e.g., IND, IMPD, facility DMF, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards

Prepare Health Authority responses & background packages (including participating/leading Health Authority meetings); and/or post-approval submissions

Independently manage and prioritize multiple complex projects

Manage and maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work

Work with the CMC teams to ensure CMC documentation (e.g., protocols, reports, specifications, analytical methods, batch records) that support development, process validation, and tech transfer activities meet regulatory standards

Support Manufacturing Change Controls for global impact and guide technical teams on global change management

Research and provide analysis of current US and international regulations and guidance

Provide ac hoc Regulatory-CMC support to RayzeBio manufacturing team

Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements

Actively participate with Global Regulatory Leads to develop content of container labels

Review and guide content of CMC information in nonclinical and clinical documents including clinical protocols, pharmacy manuals, investigator brochures, and prescribing information

Communicate critical issues to Management

Basic Qualifications: Bachelor’s degree in chemistry is highly desired

9 or more years of hands-on CMC regulatory experience, title dependent upon experience

Previous experience with radiopharmaceutical therapy (therapeutic and diagnostic), radiopharmaceutical cold kits, and/or PET drug products is a must.

Prior experience in independently authoring IND, IMPD, NDA, MAA and/or DMF CMC sections is required

Understanding of phase-appropriate data requirements for regulatory filings is desired

Demonstrable record of strong leadership and teamwork in a cross-functional industry environment

Excellent written and verbal communication skills

Preferred Qualifications: Experience with complex aseptic formulations is preferred

Experience with post-approval lifecycle management and change control

Demonstrated ability to coach and develop teams

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 start-up environment

#RayzeBio 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 . Visit 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.