We are in relentless pursuit of breakthroughs that change patients' lives. At Pfizer, we innovate every day to make the world a healthier place.
Our Mission
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
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.
Senior Manager RoW Oncology Regulatory Strategy
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.
* 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.
This role requires a strong understanding of regulatory requirements and the ability to navigate complex regulatory environments. The ideal candidate will possess excellent organizational and negotiation skills, with the ability to manage time effectively and prioritize multiple projects.
The Senior Manager RoW Oncology Regulatory Strategy will be responsible for developing and leading complex projects, working independently on self-initiated assignments, and serving as the Regulatory Liaison on project teams throughout the product lifecycle.
The successful candidate will have a strong background in regulatory affairs, with experience in drug development science and a proven track record of delivering results within a complex matrix environment.
We offer competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
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.
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.