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 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.
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
#LI-PFE #J-18808-Ljbffr
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 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.
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
#LI-PFE #J-18808-Ljbffr
