Manager, Regulatory Affairs – Project Management

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $134.5k - $163k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Plan, coordinate, and execute regulatory submissions and activities, including INDs and amendments, CTAs, NDAs, MAAs, IMPDs, briefing packages, and RFIs • Develop, maintain, and proactively manage detailed regulatory project timelines and schedules • Monitor project progress, identify risks or issues, and proactively escalate 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 with Program Management to align regulatory timelines with integrated program timelines and expectations • Facilitate cross-functional meetings and clarify roles, responsibilities, and deliverables • Prepare and maintain regulatory submission trackers and project dashboards • Document key milestones, decisions, and action items • Provide regular, clear status updates to Regulatory Affairs leadership and cross-functional teams • Report to the Head of Regulatory Project Management

🎯 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 • Strong interpersonal skills and 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 strong communication and teamwork in a cross-functional environment • Highly organized; able to manage multiple complex projects simultaneously • Ability to 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 Gantt chart software, such as MS Project and Smartsheet • Proficiency in MS Office, including Outlook, Word, PowerPoint, Excel, and Teams • Radiopharmaceutical experience • Ability to apply AI to improve team execution and decision-making

🏖️ Benefits

• Medical, pharmacy, dental, and vision care • BMS Well-Being Account • BMS Living Life Better • Employee Assistance Programs (EAP) • 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 • Survivor support • Paid Time Off • Flexible time off for US exempt employees (unlimited, with manager approval) • 11 paid national holidays • 160 hours annual paid vacation for eligible Phoenix, AZ, Puerto Rico and RayzeBio employees • 3 optional holidays for eligible Phoenix, AZ, Puerto Rico and RayzeBio employees • Unlimited paid sick time, based on eligibility • Up to 2 paid volunteer days per year, based on eligibility • Summer hours flexibility, based on eligibility • Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs • Annual Global Shutdown between Christmas and New Year's Day