Senior Associate, Early Phase, Regulatory Affairs Milano

Senior Associate, Early Phase, Regulatory Affairs
Milano
Lombardia, Milano

Senior Associate, Early Phase, Regulatory AffairsJob SummaryRepresent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolioProvide 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 goalsAccountable for timely submissions and approvals in the EU regionAccountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio within the EUJob ResponsibilitiesAccountable for ensuring EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned early-stage oncology portfolioEnsures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating submission activitiesPartners 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 standardsEnsures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management, and any risks mitigatedEnsures an aligned EU regulatory position is reached and communicated for all key issues for assigned project/sEngages in appropriate activities to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriateEnsures business compliance and implementation of and adherence to Regulatory standardsDevelops and maintains constructive working relationships with Health Authority contacts in the EU regionOrganizational RelationshipReports to early phase Oncology EU leadWorks with GRS colleagues and relevant project team(s) membersPartners with EU colleagues, including GRS-in Country colleagues and Medical colleaguesWorks directly or indirectly with external contacts in Regulatory Agencies within EU regionEnsures alignment with GRL and early phase Oncology Global HeadQualification SkillsScientific Degree.

A higher degree may be an advantage but is not essentialProven experience in managing national and/or EU regulatory process and registration aspects of the drug development processPrevious experience as a national and/or EU regulatory liaison for at least one product in different therapeutic areas and stages of the product life cycle is highly desirableExperience in communicating with major EU regulatory agency(ies) and participating in/leading such interactions is preferredKnowledge of drug development practice rules, regulations and guidelinesProven ability in developing and implementing regulatory strategyCommunication skills - Ability to communicate complex information and analyses to a variety of scientific audiencesPresentation skills - Effective in various formal presentation settingsNegotiation skills - Can negotiate skillfully in tough situations with both internal and external groupsAbout UsPfizer careers are like no other.

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