Director Regulatory CMC

At RayzeBio every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb RayzeBio blends the nimble pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here youll join a multidisciplinary team where your ideas are valued your expertise is amplified and collaboration is at the heart of everything we do. From day one expect to make an immediate impacton our science on our teams and most importantly on patients. Learn more about RayzeBio: are seeking an experienced and motivated Director in Regulatory Affairs - CMC. This position will report to the Sr. Director of Regulatory Affairs-CMC and will oversee and/or manage CMC regulatory functions 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 within the CMC team to develop and execute the CMC global regulatory strategy for RayzeBio radiopharmaceutical drugs leading to successful preparation and approval of Investigational New Drug applications (INDs) Clinical Trial Applications (CTAs) Drug Master Files (DMFs) New Drug Applications (NDA) and Marketing Authorization Application (MAA) submissions.

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

• Prepare Health Authority responses & meeting/briefing packages

• Participate/lead Health Authority meetings

• Independently manage and prioritize multiple complex projects

• Manage and maintain strong working relationships with the regulatory CMC team and cross functional teams participate in and/or lead multifunctional teams

• Lead the CMC regulatory function within cross functional teams for technology transfer to endure that deliverables align with regulatory strategy

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

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

• 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

• Research and provide analysis of current US and international regulations and guidance and activities for latest technological innovation and knowledge in radiochemistry drug development manufacture testing supply and allied functional areas in the field

• Participate in trade groups and represent RayzeBio at scientific conferences and meetings

• Communicate critical issues to Management

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) Veeva Vault/RIM systems 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

Basic Qualifications:

• Bachelors degree in chemistry or related field is highly desire OR Masters degree with 7 or more years of hands-on regulatory experience OR an advanced degree with 5 or more years of hands-on regulatory experience

• Previous experience with radiopharmaceutical therapy(therapeutic and diagnostic) radiopharmaceutical cold kits and/or PET drug products is required

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

• Understanding 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

If you come across a role that intrigues you but doesnt 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 employees 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 offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical pharmacy dental and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account BMS Living Life Better and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan short- and long-term disability life insurance accident insurance supplemental health insurance business travel protection personal liability protection identity theft benefit legal support and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited with manager approval 11 paid national holidays (not applicable to employees in Phoenix AZ Puerto Rico or Rayzebio employees)

• Phoenix AZ Puerto Rico and Rayzebio Exempt Non-Exempt Hourly Employees: 160 hours annual paid vacation for new hires with manager approval 11 national holidays and 3 optional holidays

Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year summer hours flexibility leaves of absence for medical personal parental caregiver bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio 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: Protection

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