Hub Submission Manager

2 weeks ago

Sandwich, Kent, United Kingdom Pfizer Full time

Job Description: Hub Submission Manager

Why Patients Need You

We're looking to bring medicines to the world faster and 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 medicines and vaccines.

What You Will Achieve

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. Through your comprehensive knowledge of principles, concepts, and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • 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 for the assigned assets, prepare, review, and submit submissions to relevant stakeholders, to obtain all necessary authorizations/approvals for the 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.
  • Promote the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary to produce timely delivery of submission/archive ready components.
  • 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.​
  • Support leadership to produce business processes by understanding regulatory guidelines and requirements.

​

Qualifications

Must-Have

  • 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.
  • Strong verbal and written communication skills.
  • Advanced MS Office Suite skills and strong competency with relevant tools
  • Understanding of systems and electronic technologies used to support submission and planning activities.

Nice-to-Have

  • 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 Trial Applications, and submissions management.


Work Location Assignment: Sandwich (Kent) with flexibility

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

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