Global Regulatory Strategy
4 settimane fa
Why Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer oncology medicines.
What You Will AchieveYou will represent Pfizer as an EU Regulatory Affairs Strategist in the regulatory affairs team. You will play the critical role of providing regulatory expertise with regional focus for EU to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. You will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and EMA and other regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.
As a Manager, you provide regulatory guidance to cross-functional teams for managing projects. Your planning skills will help in achieving objectives, and providing areas of improvement for products, processes or services. It is your dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve ItProvide regulatory guidance with regional focus for EU, lead/co-lead projects, manage own time to achieve objectives.Provide strategic regulatory input into WRS global regulatory strategies, thus providing optimal support for meeting local business objectives.Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.Support regulatory compliance activities with monitoring and reporting compliance in all critical points required of Worldwide Strategy and Regulatory systems.Maintain licenses in compliance with EU regulations by ensuring that corporate regulatory processes, Standard Operating Procedures (SOPs) and systems are in place.Partner with project teams and other customers to ensure regulatory contributions (Global Regulatory Strategies, labels, CTAs, MAAs, etc.) meet business needs and are provided within agreed time and quality standards.Ensure business compliance, and implementation of and adherence to regulatory standards.QualificationsMust-HaveBachelor's Degree5+ years of experienceExperience in Over the Counter or pharmaceutical industry, with experience in the global regulatory environmentRegional/Country regulatory experience including submission processes and product life cycle management activitiesKnowledge of commercial activities and Current Good Manufacturing Practices (part of GxP)Ability to work well cross functionally and to develop productive/collaborative relationshipsStrong written and verbal communication skillsNice-to-HaveMaster's degreeRelevant pharmaceutical experienceExperience of conducting, managing or participating in the audit processWork Location Assignment: On Premise
Please send resume in English
Deadline to apply: Dec 5, 2024
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 Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here
#J-18808-Ljbffr
-
Global Regulatory Strategy
2 settimane fa
Milano, Italia Pfizer A tempo pienoGlobal Regulatory Strategy - Manager Apply locations Italy - Milan, United Kingdom - Walton Oaks, United Kingdom - Sandwich Time type: Full time Posted on: Posted 2 Days Ago Job requisition id: 4924572 Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer A tempo pienoGlobal Regulatory Strategy - Manager Apply locations Italy - Milan, United Kingdom - Walton Oaks, United Kingdom - Sandwich Time type: Full time Posted on: Posted 2 Days Ago Job requisition id: 4924572 Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer A tempo pienoGlobal Regulatory Strategy - Manager Apply locations Italy - Milan, United Kingdom - Walton Oaks, United Kingdom - SandwichTime type: Full timePosted on: Posted 2 Days AgoJob requisition id: 4924572Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer A tempo pienoGlobal Regulatory Strategy - Manager Apply locations Italy - Milan, United Kingdom - Walton Oaks, United Kingdom - Sandwich Time type: Full time Posted on: Posted 2 Days Ago Job requisition id: 4924572 Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to...
-
Global Regulatory Strategy
1 mese fa
Milano, Italia Pfizer A tempo pienoWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...
-
Global Regulatory Strategy
2 giorni fa
Milano, Italia Pfizer A tempo pienoWhy Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer A tempo pienoGlobal Regulatory Strategy - ManagerApply locations Italy - Milan, United Kingdom - Walton Oaks, United Kingdom - SandwichTime type: Full timePosted on: Posted 2 Days AgoJob requisition id: 4924572Why Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity.Adhering to local and...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer A tempo pienoWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer A tempo pienoWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient...
-
Global Regulatory Strategy Expert
1 settimana fa
Milano, Lombardia, Italia Pfizer A tempo pienoPfizer is a Patient-Centric CompanyWe're looking to bring medicines to the world faster, and we're not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential, and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer, S.A. De C.V A tempo pienoWe'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...
-
Global Regulatory Strategy
3 settimane fa
Milano, Italia Pfizer A tempo pienoWhy Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity.Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail.Your dedication and expertise will help expand and accelerate patient...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer, S.A. De C.V A tempo pienoWe'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...
-
Global Regulatory Strategy
2 settimane fa
Milano, Italia Pfizer, S.A. De C.V A tempo pienoWe'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...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer, S.A. De C.V A tempo pienoWe'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...
-
Global Regulatory Strategy
4 settimane fa
Milano, Italia Pfizer, S.A. de C.V A tempo pienoWe’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...
-
Global Regulatory Strategy
2 settimane fa
Milano, Italia Pfizer, S.A. de C.V A tempo pienoWe’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...
-
Milano, Italia Pfizer A tempo pienoRepresent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio - Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST) - Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the...
-
Milano, Italia Pfizer, S.A. De C.V A tempo pienoEarly Phase, EU Regulatory Strategy Sr. Associate 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...
-
Director Regulatory Strategist
2 mesi fa
Milano, Italia Viatris A tempo pienoVIATRIS ITALIA S.R.L. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...