Manager, Regulatory Affairs Project Management

Responsibilities

• Lead the planning, coordination, and execution of regulatory submissions and activities (e.g., INDs and amendments, CTAs, NDAs, MAAs, IMPDs, briefing packages, RFIs).
• Develop, maintain, and proactively manage detailed regulatory project timelines and schedules.
• Monitor project progress, identify risks or issues, and escalate proactively with proposed mitigation strategies.
• Serve as the primary regulatory project management point of contact for assigned submissions.
• Communicate project status, risks, and progress to internal stakeholders and leadership.
• Collaborate closely with Program Management to ensure regulatory timelines align with integrated program timelines and expectations.
• Facilitate cross-functional meetings and ensure clarity of roles, responsibilities, and deliverables.
• Document key milestones, decisions, and action items.
• Provide regular, clear status updates to Regulatory Affairs leadership and cross-functional teams.

Requirements

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

Skills

• Strong interpersonal skills with the ability to build and maintain effective cross-functional relationships.
• Flexibility and adaptability in a fast-paced, dynamic development environment.
• Strong decision-making skills and ability to navigate ambiguous situations.
• Demonstrated record of strong communication and teamwork in a cross-functional environment.
• Highly organized with the ability to manage multiple complex projects simultaneously.
• Ability to think through projects 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.
• Professional, proactive, and confident approach with high ethical standards.
• Experience with all phases of clinical development.
• Proficiency in project timeline and Gannt chart software (eg, MS Project, Smartsheet), MS Office (e.g., Outlook, Word, PowerPoint, Excel, and Teams).
• Radiopharmaceutical experience.

Qualifications

• Experience with regulatory affairs, project management, life sciences, or healthcare.
• Hands-on experience supporting or leading major global regulatory submissions; NDA filing experience preferred.
• Experience supporting oncology development programs.

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: Paid Time Off, including US Exempt Employees flexible time off (unlimited, with manager approval, 11 paid national holidays), 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.