Community Hub Coordinator
2 weeks ago
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.
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 medicines and vaccines.
You will be accountable for directing the development, quality control and publication of submissions relating to asset development and registration, driving adherence to external regulatory guidelines and compliance timelines for multiple submission types. Providing strategic direction to teams on regulatory logistics, you will serve as a regulatory operational liaison on the project team throughout the product lifecycle. You will coordinate timely provision of product information through submissions that conform to external and internal requirements, authoring and redacting content as applicable based on external regulations and submitting product information to regulatory authorities.
As a manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements and providing areas of improvement for products, processes,or services. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the department.
Drive global submission management activities fortheassigned assets, prepare,review,and submit submissions torelevant stakeholders, to obtain all necessary authorizations/approvalsforthe clinical trials.
Coordinate submission production and assist with definition, development and implementation of global submissions policies and technologies to meet evolving business needs.
Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
Lead the interpretation of dossier requirements to produce business processes and ensure that those processes are implemented where appropriate at global and local level.
Implement strategies that achieve operational excellence through interaction with global regulatory leaders and associated product teams.
Bachelor's Degree(BA/BS)and be able to showcase extensive demonstrable years of experience.
Significant knowledge of the drug development process, Regulatory Affairs,and submissions management.
Advanced MS Office Suite skills and strong competency with relevant tools
Understanding of systems and electronic technologies used to support submission and planning activities.
Master's degree(MA/MBA/MS)and be able to showcase applicable years of experience.
Doctorate(PhD/PharmD/JD).
Knowledge of pharmaceutical organizational structures, systems, and culture
Strong knowledge of the drug development process, regulatory affairs, Clinical TrialApplications,and submissions management.
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.
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.We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms – allowing for us to be as diverse as the patients and communities we serve. 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. Your journey with Pfizer starts here
Regulatory Affairs#LI-PFE
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