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Bristol Myers Squibb logo
Bristol Myers Squibb

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. 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.

Senior Director, Regulatory Affairs - Early Development

DirectorDirectorFull TimeRemoteLeadTeam 10,001

Location

United States

Posted

110 days ago

Salary

$241K - $316K / year

Seniority

Lead

No structured requirement data.

Job Description

Senior Director, Regulatory Affairs - Early Development

Bristol Myers Squibb

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, you’ll 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 impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ 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 Job Description We are seeking an experienced and innovative Senior 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 Early Development regulatory functions and direct reports within RayzeBio. Responsibility expectations will be commensurate with experience. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. - Global Regulatory Lead for cutting edge radiopharmaceutical programs. - Clinical and nonclinical regulatory strategy for therapeutic and diagnostic radiopharmaceutical products, including timing and nature of global regulatory interactions. - Experience in clinical regulatory strategy in the Early Development or first-in-human space. - 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 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. - Responsible for direct reports. Basic Qualifications - Bachelor’s degree or higher - 10 or more years of hands-on regulatory experience, including authoring and providing strategic input to stakeholders - Experience with nonclinical and clinical regulatory strategy in oncological indications - Demonstrable record of strong leadership and teamwork in a cross-functional 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 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. Compensation Overview: Remote - United States - US: $241,768 - $292,966 San Diego - RayzeBio - CA: $261,110 - $316,404 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 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 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. 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: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. R1600115 : Senior Director, Regulatory Affairs - Early Development

Job Requirements

  • Bachelor’s degree or higher.
  • 10 or more years of hands-on regulatory experience, including authoring and providing strategic input to stakeholders.
  • Experience with nonclinical and clinical regulatory strategy in oncological indications.
  • Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.
  • 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.

Benefits

  • 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: flexible time off (unlimited, with manager approval), 11 paid national holidays.
  • 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.

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Director110 days ago

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NTT Global Data Centers logo

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Director110 days ago
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You steer the programmatic direction for one of our largest, most dynamic clients, moving beyond the tactical to act as a senior consultant on automated buying. You are responsible for identifying how programmatic can bridge the gap between brand awareness and performance, while navigating the complexities of an evolving, privacy-first digital landscape. As a leader within the craft, you ensure our strategies are not only meeting KPIs but pushing the boundaries of what automated media can achieve. WHAT YOU’LL DO: - Strategic Oversight: Steer the programmatic strategy for a high-profile, high touch client, ensuring that automated media buying is integrated into their broader business and marketing goals. - Executional Rigor: Ensure exceptional accuracy, thoroughness, and organization across all deliverables, effectively balancing competing priorities with a proactive, solutions-oriented mindset. - Data Innovation: Direct the implementation of 1st and 3rd party data strategies, helping clients navigate the cookie-less future through identity solutions and privacy-centric targeting. - Senior Client Advisory: Act as a trusted advisor to senior client stakeholders, translating technical programmatic complexities into clear business value and growth opportunities. - Technology Evaluation: Lead the evaluation and onboarding of new programmatic tech partners, including DSPs, SSPs, and Dynamic Creative Optimization (DCO) platforms. - Total Media Synergy: Partner with Search and Social leads to drive a "Total Media" approach, ensuring programmatic inventory complements other digital touchpoints. - Team Leadership: Manage and mentor a team of Managers and Associates, overseeing their tactical output and providing a clear path for their professional development. WHAT YOU BRING: - 5–7 years of programmatic experience, with a proven track record of strategic planning and account leadership within an agency setting. - Expertise in the Ecosystem: Deep knowledge of the programmatic landscape, including SSP dynamics, Header Bidding, Clean Rooms, and Attribution modeling. - Platform Mastery: Advanced proficiency in multiple DSPs (e.g., The Trade Desk, DV360, Amazon DSP, Walmart Connect) Google Ads and Ad Servers (CM360). - Leadership Presence: The ability to influence cross-functional teams and build implicit trust with senior client stakeholders. - Analytical Vision: You can interpret complex data sets to identify high-level trends and provide strategic recommendations that move "hearts and minds." - Proactive Problem Solving: A "get sh*t done" mentality when it comes to troubleshooting technical issues or navigating industry shifts. - Better Together Spirit: A passion for collaboration and a commitment to nurturing talent within the Programmatic craft. WHAT DO WE OFFER? - Healthcare, Dental, and Vision coverage - 401K plan, plus matching - PTO - Paid Company Holidays - Parental Leave WE SUPPORT YOU BEING YOU: DEPT® is an equal opportunity employer (EOE). We believe our work is its best when our people feel safe and free to be themselves. We’re committed to an inclusive and barrier-free recruitment and selection process and workplace, regardless of anyone’s identity, background, beliefs, lifestyle, or disabilities. So tell us about any accommodations you need. It’s totally confidential and only used to make sure you feel fully supported at every step. DEPT® participates in E-Verify, meaning your Form I-9 information will be sent to the federal government to confirm you are authorized to work in the U.S. We are a B Corp-certified company passionate about purpose-driven work. Our hope is that you can feel good about the contributions DEPT® is making to the world and we always have an open door for your ideas in making the world a better place. DEPT® is a Growth Invention company built to help the world’s most ambitious brands grow faster. Operating at the intersection of technology and marketing, our 4,000+ specialists deliver growth invention across Brand & Media, Experience, Commerce, CRM, and Technology & Data. We’re 50|50 tech and marketing, partner-led, and first to move. Clients include Google, Lufthansa, Coach, eBay, and OpenAI. Learn more about DEPT® DIVERSITY, EQUITY, & INCLUSION At DEPT®, we take pride in creating an inclusive workplace where everyone has an equal opportunity to thrive. We actively seek to recruit, develop, nurture, and retain talented individuals from diverse backgrounds, with varying skills and perspectives. Not sure you meet all qualifications? Apply, and let us decide! Research shows that women and members of underrepresented groups tend not to apply for jobs when they think they may not meet every requirement, when in fact they do. We believe in giving everyone a fair chance to shine. We also encourage you to reach out to us and discuss any reasonable adjustments we can make to support you throughout the recruitment process and your time with us. Want to know more about our dedication to diversity, equity, and inclusion? Check out our efforts here. #LI-remote The anticipated salary range for this position is listed below. Salary is based on a range of factors that include relevant experience, expertise, physical location, and organizational impact. This is based on a 40-hour workweek and leveling. Keep in mind, we’re flexible. US Remote Range $110,000—$120,000 USD

United States
$110K - $120K / year
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