Global Regulatory Strategy

4 settimane fa

Milano, Italia Pfizer, S.A. De C.V A tempo pieno

We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
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.
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 Relevant pharmaceutical experience
Experience of conducting, managing or participating in the audit process
Please send resume in English.
Deadline to apply: Dec 5, 2024.

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