Hub Submission Manager

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 access to Pfizer medicines and vaccines.

You will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be accountable for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical submissions on time. Your innovative use of communication tools and techniques will facilitate in addressing difficult issues and establishing consensus between teams.

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

• Contribute to the completion of complex projects, manage own time to meet established targets and develop plans for work activities on own projects within a team.
• Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
• Handle the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local/regional level.
• Work with the team managers to effectively forecast and manage project specific resources utilizing flexible resourcing and global load sharing as normal business practice.
• Operate as Subject Matter Expert in dossier types and processes with accountability for training and mentoring fellow colleagues.
• Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
• Lead the implementation and execution of withdrawal strategy in partnership with regulatory strategy.
• Accountable for updating the Regulatory parameters for monthly reports to local and global customers.
• Cover allocated region/countries, with additional accountability to support other locations through utilization of global tools.
• Able to follow scientific arguments and ensure data is complete and sound.
• Ensure maintenance of product and license information in the tracking database.
• Accountable for curriculum and training assignments and assist in the collection of training metrics and produces compliance figures for distribution.

• Bachelor's Degree
• Strong experience
• Relevant experience in electronic submissions build within the Pharmaceutical Industry
• Strong knowledge of the drug development process, regulatory affairs, and submission management
• Handling of systems and electronic technologies used to promote submission and planning activities
• Attention to detail and exceptional organizational skills
• Presents scientific data effectively, in verbal and written in a logical and persuasive manner
• Proven experience managing or delivering through others in a team environment
• Proficient in English, verbal and written

• Master's degree
• Relevant pharmaceutical experience
• Familiarity with pharmaceutical organizational structures, systems, and culture
• Experience in project management

  
Work Location Assignment: Flexible

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