Senior Regulatory Associate, Early-Stage Oncology

4 settimane fa

Milano, Lombardia, Italia Pfizer A tempo pieno

Job Overview

Act as the representative for the EU region (including EU, UK, CH, NZ, AUS) in regulatory sciences concerning the designated early-phase oncology portfolio. Offer regional strategic insights as a member of the Global Regulatory Strategic Team (GRST). Spearhead and execute EU regulatory strategies in collaboration with key stakeholders for assigned projects/products, aligning with company objectives. Responsible for ensuring timely submissions and approvals within the EU region. Ensure optimal regulatory engagement with Health Authorities regarding the designated early-stage oncology portfolio in the EU.

Key Responsibilities

Ensure EU contributions to Global Regulatory Strategies and implementation plans (including core labels and risk registers) for the assigned early-stage oncology portfolio. Guarantee regulatory contributions meet strategic objectives, adhere to agreed standards, and maximize overall project delivery timelines and success probabilities while facilitating submission activities. Collaborate with project teams to ensure that necessary regulatory contributions (e.g., CTA) fulfill business requirements and are delivered to agreed timelines and quality standards. Monitor regulatory plans, communicate progress and variances to the GRL and Senior Management, and mitigate any risks arising from emerging technical data, shifting internal objectives, or external threats. Achieve and communicate a unified EU regulatory stance on all critical issues for assigned projects, ensuring that these positions support the EU business and are effectively championed. Engage in relevant activities to influence the EU regulatory landscape through collaboration with GRS-In Country colleagues, Agency contacts, and/or Trade Associations as necessary. Ensure compliance with business regulations and adherence to Regulatory standards. Cultivate and maintain constructive working relationships with Health Authority contacts in the EU region, either directly or indirectly.

Organizational Structure

Reports to the early-phase Oncology EU lead. Collaborates with GRS colleagues and relevant project team members (including Clinical and Project Management, Development Operations, Global Regulatory Sciences, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance, and Legal). Partners with EU colleagues, including GRS-in Country and Medical colleagues, to establish an EU position. Works directly or indirectly with external contacts in Regulatory Agencies within the EU region. Ensures alignment with the GRL and the early-phase Oncology Global Head.

Required Qualifications

A scientific degree; a higher degree may be advantageous but is not mandatory. Demonstrated experience in managing national and/or EU regulatory processes and registration aspects of drug development, particularly clinical trials experience in at least one country. Previous experience as a national and/or EU regulatory liaison for at least one product across various therapeutic areas and stages of the product life cycle is highly desirable. Equivalent experience at a regulatory agency or in substantive industry-government collaborations may be considered. Experience in communication with major EU regulatory agencies, including participation in or leading such interactions, is preferred. Knowledge of drug development practices, rules, regulations, and guidelines, including familiarity with factors likely to influence the regulatory environment, such as new and emerging guidelines. Proven ability to develop and implement regulatory strategies, with an understanding of regulatory agency philosophies and guidelines. Experience in preparing and submitting CTAs is essential. Strong communication skills, with the ability to convey complex information and analyses to diverse scientific audiences in both verbal and written formats, including to senior management. Effective presentation skills across various formal settings, including one-on-one, small and large groups, with peers, direct reports, and senior management. Negotiation skills, capable of navigating challenging situations with both internal and external groups, demonstrating both directness and diplomacy while quickly gaining the trust of other parties involved in negotiations.

Company Mission

Breakthroughs that change patients' lives ... At Pfizer, we are dedicated to a patient-centric approach, guided by our core values: courage, joy, equity, and excellence. Our culture of breakthroughs drives our commitment to transforming millions of lives.

Digital Transformation Initiative

A key component of our mission is our comprehensive digital transformation strategy. We are at the forefront of adopting innovative data, modeling, and automated solutions to further digitize and expedite drug discovery and development, ultimately enhancing health outcomes and the patient experience.

Workplace Flexibility

We strive to foster a trusting and flexible workplace culture that encourages employees to achieve work-life harmony, attracts top talent, and enables everyone to perform at their best.

Commitment to Diversity

We believe that a diverse and inclusive workforce is essential for building a successful business. As an employer, Pfizer is committed to celebrating diversity in all its forms, allowing us to reflect the patients and communities we serve. Together, we continue to cultivate a culture that encourages, supports, and empowers our employees.

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