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 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 represent Pfizer as an EU Strategist in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product(s) lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, renewals, variations, amendments, and periodic safety reports.

As a manager, you provide guidance to Global cross functional teams for managing projects. Your planning skills will help in preparing submission plans, and continuous areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts and theories of regulatory affairs, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate working across different teams.

It is your dedication that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Provide regulatory guidance, lead/co-lead projects, manage own time to meet regulatory objectives, and plan resource requirements for projects across the division.

• Liaise with and provide input/direction to Global Chemistry Manufacturing and Controls, Global labelling and any other key stakeholder to ensure the filing strategies for initial registrations and the lifecycle submissions are defined and executed and the BoH requirements are met, ensuring a submission ready dossier.

• Work in collaboration across the organization with stakeholders to deliver efficiencies in regulatory submissions and improve Pfizer processes.

Qualifications

Must-Have

• Bachelor's Degree

• Demonstrable experience of effective delivery in a complex matrix environment

• Regulatory experience including knowledge of EU submission processes (National, MRP-DCP and CAP)

• In depth knowledge of national/regional regulatory legislation and guidelines

• Knowledge of relevant pharmaceutical disciplines e.g. chemistry/manufacturing/quality/pharmacology/medical or safety

• Leadership qualities and management skills, team oriented with problem solving skill strong written and verbal communication and interpersonal skills

Nice-to-Have

• Master's degree

• Relevant pharmaceutical experience in another discipline

  
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!