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 oncology medicines.
What You Will Achieve
You will represent Pfizer as an EU Regulatory Affairs Strategist in the regulatory affairs team. You will play the critical role of providing regulatory expertise with regional focus for EU to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. You will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and EMA and other regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.
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As a Manager, you provide regulatory guidance to cross-functional teams for managing projects. Your planning skills will help in achieving objectives, and providing areas of improvement for products, processes or services. It is your dedication and focus 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 with regional focus for EU, lead/co-lead projects, manage own time to achieve objectives.
- Provide strategic regulatory input into WRS global regulatory strategies, thus providing optimal support for meeting local business objectives
- Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
- Support regulatory compliance activities with monitoring and reporting compliance in all critical points required of Worldwide Strategy and Regulatory systems.
- Maintain licenses in compliance with EU regulations by ensuring that corporate regulatory processes, Standard Operating Procedures (SOPs) and systems are in place.
- Partner with project teams and other customers to ensure regulatory contributions (Global Regulatory Strategies, labels, CTAs, MAAs, etc.) meet business needs and are provided within agreed time and quality standards.
- Ensure business compliance, and implementation of and adherence to regulatory standards.
Qualifications
Must-Have
- Bachelor's Degree
- 5+ years of experience
- Experience in Over the Counter or pharmaceutical industry, with experience in the global regulatory environment
- Regional/Country regulatory experience including submission processes and product life cycle management activities
- Knowledge of commercial activities and Current Good Manufacturing Practices (part of GxP)
- Ability to work well cross functionally and to develop productive/collaborative relationships
- Strong written and verbal communication skills
Nice-to-Have
- Master's degree
- Relevant pharmaceutical experience
- Experience of conducting, managing or participating in the audit process
Work Location Assignment: On Premise
Please send resume in English
Deadine to apply: Dec 5, 2024
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 Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Regulatory Affairs
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