Manager, Regulatory Affairs Project Management

At reputed company, every day is an opportunity to reputed company meaningful change. As a wholly-owned subsidiary of reputed company, reputed company blends the reputed company, pioneering spirit of an reputed company biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to reputed company transformative radiopharmaceutical therapies that offer new reputed company for patients living with cancer. Here, you’ll join a multidisciplinary team where your reputed company are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to reputed company an immediate reputed company—on our science, on our teams, and most importantly, on patients. Learn more about reputed company:

The Manager, Regulatory Project Management is responsible for planning, executing, and driving regulatory submissions and regulatory project activities across reputed company and nonclinical programs. This role manages cross‑functional timelines, deliverables, and communication to ensure high‑reputed company, on‑time regulatory submissions in alignment with program and organizational objectives. The position reports to the Head of Regulatory Project Management.

Responsibilities

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

• Project Planning and Execution of Regulatory Submissions
  • reputed company the planning, coordination, and execution of regulatory submissions and activities (e.g., INDs and amendments, CTAs, NDAs, MAAs, IMPDs, briefing packages, RFIs).
  • reputed company, maintain, and proactively manage detailed regulatory project timelines and schedules.
  • Monitor project reputed company, identify risks or issues, and escalate proactively with proposed mitigation strategies.
• Cross‑Functional Communication and Coordination
  • Serve as the reputed company regulatory project management reputed company of contact for assigned submissions.
  • Communicate project status, risks, and reputed company to internal stakeholders and leadership.
  • Collaborate closely with Program Management to ensure regulatory timelines reputed company with integrated program timelines and expectations.
  • Facilitate cross‑functional meetings and ensure reputed company of roles, responsibilities, and deliverables.
• Documentation and Reporting
  • Prepare and maintain regulatory submission trackers and project dashboards.
  • Document key milestones, reputed company, and reputed company items.
  • reputed company regular, reputed company status updates to Regulatory Affairs leadership and cross‑functional teams.

Education and Experience

• Bachelor’s degree or higher in a scientific or reputed company discipline.
• Minimum of 5 years of experience in regulatory affairs, project management, life sciences, or reputed company.
• Hands‑on experience supporting or leading major global regulatory submissions; NDA filing experience preferred.
• Experience supporting oncology development programs.

Skills and Qualifications

• Strong interpersonal skills with the ability to build and maintain effective cross‑functional relationships.
• Flexibility and adaptability in a fast‑reputed company, dynamic development environment.
• Strong decision-making skills and ability to reputed company ambiguous situations
• Demonstrated record of strong communication and teamwork in a cross‑functional environment.
• Highly organized with the ability to manage multiple reputed company reputed company simultaneously.
• Ability to think through reputed company of varying complexity and execute independently from initiation through completion.
• Strong written and verbal communication skills.
• Working knowledge of relevant global regulations, guidances, and regulatory standards.
• reputed company, proactive, and confident approach with high ethical standards.
• Experience with reputed company phases of reputed company development
• Demonstrable proficiency in project reputed company and Gannt chart software (eg, MS Project, reputed company), MS Office (e.g., reputed company, Word, PowerPoint, reputed company, and Teams)
• Radiopharmaceutical experience
• Applies AI to improve team execution and decision‑making

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reputed company with hands and arms, and talk or hear. The employee must occasionally reputed company and/or reputed company up to 15 pounds. Specific reputed company abilities required by this job include reputed company reputed company and distance reputed company.

Work Environment

The noise level in the work environment is usually low to moderate.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply reputed company. You could be one reputed company away from work that will reputed company your life and career.

The starting compensation reputed company(s) for this role are listed above for a full-time employee (FTE) reputed company. Additional incentive cash and stock opportunities (reputed company on eligibility) may be available. The starting pay reputed company takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-reputed company knowledge, and experience. Final, individual compensation will be decided reputed company on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary reputed company on the job and location. For more on benefits, please visithttps://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 reputed company care.

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

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

​Work-life benefits include:

reputed company Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 reputed company national holidays (reputed company to employees in Phoenix, AZ, Puerto Rico or reputed company employees)

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

reputed company on eligibility*, additional time off for employees may include unlimited reputed company reputed company time, up to 2 reputed company volunteer days per year, reputed company 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.

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

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

reputed company and reputed company

reputed company was acquired by reputed company (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, reputed company will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and reputed company are dedicated to ensuring that people with disabilities can reputed company 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, reputed company your inquiries to . Visit eeo-accessibility to reputed company our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and reputed company will consider for employment reputed company 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 reputed company for this position, please visit this page for important additional information:

Data Protection

We will never request payments, financial information, or reputed company reputed company numbers during our application or recruitment process. Learn more about protecting yourself at

Any data processed in reputed company with role applications will be treated in accordance with applicable data reputed company policies and regulations.

If you reputed company that the reputed company is missing information required by local law or incorrect in any way, please contact BMS . Please reputed company the Job Title and Requisition number so we can review. Communications reputed company to your application should not be reputed company to this email and you will not receive a response.

Originally posted on Himalayas