Senior Associate, Early Phase Oncology, Regulatory, Milan Milano

Senior Associate, Early Phase Oncology, Regulatory, Milan
Milano
Lombardia, Milano

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Senior Associate, Early Phase Oncology, Regulatory, MilanClient: Location: Job Category: Other

EU Work Permit Required: Yes

Job Reference: 80a5042e2c21

Job Views: 3

Posted: 22. 01. 2025

Expiry Date: 08. 03. 2025

Job Description:Job Summary Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio. Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST). Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the company goals. Accountable for timely submissions and approvals in the EU region. Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio within the EU. Job Responsibilities Accountable for ensuring EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned early-stage oncology portfolio. Ensures regulatory contributions achieve the objectives in the strategy, agreed standards, maximizing overall project delivery time and probability of success, and facilitating submission activities. Partners with project teams to ensure required regulatory contributions (CTA, etc. )

meet business needs and are provided to the project teams, to agreed time and quality standards. Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management, and any risks mitigated. Ensures an aligned EU regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the EU business are championed and communicated. Engages in appropriate activities to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate. Ensures business compliance and implementation of and adherence to Regulatory standards. Develops and maintains constructive working relationships with Health Authority contacts in the EU region. Organizational Relationship Reports to early phase Oncology EU lead. Works with GRS colleagues and relevant project team(s) members (i. e.

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 colleagues and Medical colleagues, to provide an EU position. Works directly or indirectly with external contacts in Regulatory Agencies within the EU region. Ensures alignment with GRL and early phase Oncology Global Head. Qualifications Scientific Degree.

A higher degree may be an advantage but is not essential. Proven experience in managing national and/or EU regulatory processes and registration aspects of the drug development process, particularly clinical trials experience in at least one country. Previous experience as a national and/or EU regulatory liaison for at least one product in different therapeutic areas and different stages of the product life cycle is highly desirable. Experience in communicating with major EU regulatory agencies, as well as participating in/leading such interactions, is preferred. Knowledge of drug development practice rules, regulations and guidelines; familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines. Proven ability in developing and implementing regulatory strategy; understanding of regulatory agency philosophy and guidelines; experience preparing and submitting CTAs. Communication skills: ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management. Presentation skills: effective in various formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior management. Negotiation skills: can negotiate skillfully in tough situations with both internal and external groups; can be direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations. 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.

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, modeling, 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 that encourages employees to achieve work-life harmony, attracts talent, and enables everyone to be their best working self.

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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 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.

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