Regulatory Project Management

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.

Senior Manager of Regulatory Project Management will plan, execute and oversee regulatory submissions and projects and manage cross-functional relationships to achieve on-time completion of submissions. This position will report to Head of Regulatory Affairs.

Responsibilities

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

• Project Planning and Execution of Regulatory Submissions (e.g., IND, CTA, NDA, MAA, IMPD, simplified dossiers, briefing packages, RFI)

  • Develop and maintain project timelines and schedules

  • Define project scope, objectives and deliverables

  • Create and manage project plans, including resource allocation and task assignments

  • Monitor project progress, identify potential issues and escalate to stakeholders as needed

• Cross-functional Communication

  • Communicate project status and progress to internal and external stakeholders

  • Collaborate with Program Management to ensure regulatory timelines are in alignment with company program timelines and expectations.

  • Manage expectations and address concerns of stakeholders

  • Collaborate with cross-functional teams to ensure project success

• Documentation and Reporting

  • Prepare and maintain regulatory submission trackers

  • Document project milestones and report progress against team, department and corporate goals

  • Provide regular updates on project progress and status to management and cross-functional teams

Basic Qualifications:

• Bachelor’s degree or higher

• A minimum of 5 years of experience in regulatory project management

• Hands-on experience with NDA filing is a must

• Oncology Regulatory PM experience

Preferred Qualifications:

• Experience with MAA, CTA, and IND

• Familiarity with animal toxicity studies to facilitate Early Human Imaging studies

• Demonstrable proficiency in project timeline and Gannt chart software (eg, OnePager, MS Project, Smartsheet), MS Office (eg, Outlook, Word, PowerPoint, Excel, and Teams), Adobe Acrobat Pro and video conferencing

Skills and Qualifications

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

• 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

• Excellent communication skills (both written and verbal)

• Excellent interpersonal skills (ability to build and maintain strong cross-functional relationships)

• Knowledge of relevant regulations, guidances and standards

• Should be assertive, proactive, professional, and confident

• Excellent professional ethics and integrity

• Flexibility to adapt in a cross-functional and dynamic environment

The starting compensation for this job is a range from $149,860 t