Sr Manager RoW Oncology Regulatory Strategy We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals. Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. SENIOR MANAGER RoW (Rest of World) ONCOLOGY REGULATORY STRATEGY JOB SUMMARY Your work will be instrumental in maintaining the highest standards of regulatory compliance, which is essential for expanding and accelerating patient access to Pfizer's innovative treatments. Your dedication and expertise will help us navigate the complex and ever-changing regulatory landscape, ensuring that we adhere to both local and global regulations without compromising on excellence and integrity. By doing so, you will contribute significantly to our mission of improving global health efficiently and ethically. What You Will Achieve In this role, you will: Develop and lead complex projects, managing plans to achieve objectives and applying discipline knowledge to contribute to the Sub Business Unit. Work independently on self-initiated assignments, using your knowledge and experience to achieve desired results, and review work indirectly through consultation and agreement. Serve as the Regulatory Liaison on project teams throughout the product lifecycle, interacting with regulatory agencies and negotiating to expedite the approval of pending registrations. Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports, collaborating closely with Regulatory Strategists across various sites. Implement and refine systems, processes, and procedures to enhance regulatory strategy productivity, ensuring seamless information sharing across relevant lines. Foster and maintain constructive relationships with Health Authority contacts, monitor regulatory plans, communicate progress and variances to senior management, and mitigate any identified risks. Stay informed about applicable regulations and guidance, updating project teams on new information and its potential impact, and contribute to the development and execution of Regional and Global Regulatory Strategies. Set and communicate timelines for regulatory submissions, create and maintain comprehensive submission documentation, and ensure uniformity in processes, systems, and quality standards while sharing best practices and learnings. Here Is What You Need (Minimum Requirements) BA/BS with strong expert knowledge and experience; or MBA/MS with extensive role-related knowledge and experience; or PhD/JD with demonstrable applicable experience; or MD/DVM with any years of experience. Strong organizational and negotiation skills. Ability to manage time effectively to prioritize multiple projects. Excellent verbal and written communication skills. Proven experience in delivering results within a complex matrix environment. Advanced proficiency in Microsoft Office Suite. Strong competency with various regulatory tools and systems. Bonus Points If You Have (Preferred Requirements) Basic knowledge in drug development science. Strong problem-solving skills and ability to make decisions in complex situations. High level of attention to detail and accuracy. Strong leadership skills and ability to mentor and guide team members. Ability to adapt to changing regulatory environments and requirements. Work Location Assignment: Sandwich (Kent) or Milan (Italy) with the possibility of hybrid working per the current company guidelines. Purpose Breakthroughs that change patients' lives At Pfizer we are a patient-centric company, guided by our four values: courage, joy, equity, and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. One bold way we are achieving our purpose is through our company-wide digital transformation strategy. We are leading the way in adopting new data, modeling, and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture that encourages employees to achieve work-life harmony, attracts talent, and enables everyone to be their best working self. Let’s start the conversation We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports, and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here J-18808-Ljbffr