Manager, Regulatory Affairs Project Management

Company: Bristol Myers Squibb (RayzeBio Subsidiary)

Imagine a career where your daily work genuinely helps transform patient lives. At RayzeBio, an agile subsidiary of Bristol Myers Squibb, we’re pioneering transformative radiopharmaceutical therapies, blending the innovative spirit of a biotech startup with the global expertise of an oncology leader. Our shared mission is to bring new hope to patients battling cancer. In this crucial, fully remote role, open to talent worldwide, you will join our multidisciplinary team as a Manager, Regulatory Affairs Project Management. You’ll be at the heart of planning, executing, and driving essential regulatory submissions, making an immediate and profound impact on our science, our teams, and most importantly, on the patients we serve.

Overview

The Manager, Regulatory Affairs Project Management is a key player in our mission, taking responsibility for the planning, execution, and expert driving of regulatory submissions and related project activities across both clinical and nonclinical programs. You will skillfully manage cross-functional timelines, crucial deliverables, and vital communication threads. Your goal is ensuring the delivery of high-quality, on-time regulatory submissions, always in perfect alignment with our overarching program and organizational objectives. This important position reports directly to the Head of Regulatory Project Management.

Key Responsibilities

Lead the strategic planning and scheduling of regulatory project activities, ensuring alignment with global regulatory strategies and program goals.
Manage complex cross-functional timelines, coordinating deliverables from various internal teams and external partners to support successful submissions.
Facilitate effective communication among project stakeholders, regulatory authorities, and internal teams, ensuring clarity and transparency.
Monitor regulatory project progress, identify potential risks, and proactively develop mitigation strategies to keep projects on track.
Oversee the preparation, review, and quality control of regulatory submission documents, ensuring adherence to all applicable regulatory requirements.
Drive the execution of regulatory submission plans across the clinical and nonclinical development lifecycle.
Contribute to the continuous improvement of regulatory project management processes and tools.

Requirements

A Bachelor's degree in a scientific or related discipline is required; an advanced degree (MS, PharmD, PhD) is a plus.
Minimum of 5 years of experience in Regulatory Affairs or Regulatory Project Management within the pharmaceutical or biotechnology industry.
Demonstrated success in managing and driving complex regulatory submissions across various development phases (e.g., INDs, CTAs, NDAs/BLAs).
Strong understanding of global regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
Exceptional project management skills, including planning, organization, risk management, and stakeholder communication. PMP certification is advantageous but not mandatory.
Proven ability to lead cross-functional teams and influence without direct authority.
Excellent written and verbal communication abilities, with keen attention to detail.
Proficiency with project management software and tools.

What You'll Gain

Joining RayzeBio means stepping into an environment where your contributions directly shape the future of cancer treatment. You will:

Play a critical role in bringing innovative radiopharmaceutical therapies to patients globally.
Work alongside brilliant, multidisciplinary teams in a highly collaborative and supportive culture.
Benefit from the nimble, entrepreneurial spirit of RayzeBio combined with the robust resources of Bristol Myers Squibb.
Experience significant professional growth and development in a dynamic, rapidly evolving field.
Enjoy the flexibility and autonomy of a fully remote, worldwide opportunity.