SENIOR MANAGER RoW (Rest of World) ONCOLOGY REGULATORY STRATEGY

JOB SUMMARY

Use Your Power for Purpose

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 UnitWork independently on self-initiated assignments, using your knowledge and experience to achieve desired results, and review work indirectly through consultation and agreementServe as the Regulatory Liaison on project teams throughout the product lifecycle, interacting with regulatory agencies and negotiating to expedite the approval of pending registrationsDevelop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports, collaborating closely with Regulatory Strategists across various sitesImplement and refine systems, processes, and procedures to enhance regulatory strategy productivity, ensuring seamless information sharing across relevant linesFoster and maintain constructive relationships with Health Authority contacts, monitor regulatory plans, communicate progress and variances to senior management, and mitigate any identified risksStay 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 StrategiesSet 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 experienceStrong organizational and negotiation skillsAbility to manage time effectively to prioritize multiple projectsExcellent verbal and written communication skillsProven experience in delivering results within a complex matrix environmentAdvanced proficiency in Microsoft Office SuiteStrong competency with various regulatory tools and systems

Bonus Points If You Have (Preferred Requirements)

Basic knowledge in drug development scienceStrong problem-solving skills and ability to make decisions in complex situationsHigh level of attention to detail and accuracyStrong leadership skills and ability to mentor and guide team membersAbility 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.  

Digital Transformation Strategy

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, modelling 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 which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

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!

Regulatory Affairs

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