Regulatory Strategist Manager
Pfizer Inc.
Walton Oaks, United Kingdom
Job posting number: #7134762 (Ref:pf-4880576)
Posted: March 17, 2023
Application Deadline: Open Until Filled
Job Description
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!
Regulatory Affairs#LI-PFEPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.