Senior Director, Regulatory Affairs - CMC

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.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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 Senior Director, Regulatory Affairs - CMC (Manufacturing). This position will report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis. Responsibility expectations will be commensurate with experience.

Responsibilities:

• Work with the Indianapolis facility teams (QA, QC, Operations, Manufacturing, Development, Validation, etc.) to provide on-site regulatory decision making and support for RayzeBio-manufactured radiopharmaceuticals to generate documentation leading to successful preparation and approval of Investigational New Drug applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), Drug Master Files (DMFs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions

• Lead the development and execution of global CMC regulatory strategies for activities conducted at the Indianapolis manufacturing facility

• Responsible for content development, compilation, maintenance, and review of the facility DMF and/or authoring the facility-based Quality Modules in regulatory applications (e.g., IND, IMPD, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards

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

• Prepare Health Authority responses & background packages (including participating/leading Health Authority meetings)

• Author and prepare submissions for post-approval manufacturing changes (annual reports, CBEs, PAS, supplements)

• Independently manage and prioritize multiple complex projects, programs and workload.

• Manage and maintain strong working relationships with the Indianapolis facility teams, remote and SD teams, participate in and/or lead multifunctional teams

• Manage Regulatory Affairs – CMC staff

• Assess manufacturing Change Controls for global impact and guide technical teams on global change management

• Provide additional ad hoc Regulatory-CMC support to RayzeBio manufacturing team

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

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

• Communicate critical issues to Leadership

Basic Qualifications:

• Bachelor’s degree with 10 or more years of hands-on regulatory CMC experience OR an advanced degree with at least 7 years of hands-on regulatory CMC experience

• Experience with independently authoring IND, IMPD, NDA, MAA and/or DMF CMC sections

• Radiopharmaceutical experience

• Understanding of phase-appropriate data requirements for regulatory filings

• Experience with aseptic processing

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

Preferred:

• Radiopharmaceutical experience with diagnostics and therapeutics

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

#RayzeBio

The starting compensation for this job is a range is from $241,768 to $293,000 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. 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.

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.

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 adastaffingsupport@bms.com. 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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