EU Lead - Oncology Regulatory Strategy - Early phase page is loaded EU Lead - Oncology Regulatory Strategy - Early phase Apply locations Italy - Milan United Kingdom - Walton Oaks time type Full time posted on Posted Yesterday job requisition id 4915901 Job Summary Primary representative for EU (EU, UK, CH, AUS, NZ) regulatory strategy for the designated early phase Oncology portfolio, Oversee and contribute to the development of EU regional strategies for the designated early phase Oncology portfolio as a member of the Global Regulatory Strategic Team (GRST).Lead, oversee, and/or implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goalsSupervise EU regulatory strategists, and be accountable for staff and talent development, career development and planning and performance management.Accountable for timely submissions and approvals in the EU for the designated early phase Oncology portfolioAccountable for ensuring optimal regulatory interactions with EU Health Authorities for programs in the designated early phase Oncology portfolioContribute to the EU Oncology Regulatory Strategy Leadership Team and drive the required culture and behaviors through the organizationChampion flexible approaches to ensure efficient and effective resource utilizationRole can be combined with other Regulatory Role(s) (i.e. , Global Regulatory Lead)Job responsibilities Is the senior global representative for EU regulatory strategy for the designated early phase Oncology portfolio including strategic and technical contributionsProvides EU regulatory expertise and leadership within the designated early phase Oncology portfolioEnsure regional EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned products/projectsEnsures EU regulatory contributions achieve the objectives against agreed standards, maximizing overall project delivery time and probability of success and facilitating post-filing activitiesPartners with project teams and other customer groups (e.g. Regional Commercial Teams) to ensure required regulatory contributions (line plans, label, 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 (from emerging technical data, changing internal objectives or external threats) mitigatedEnsures 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 Engages/contributes in appropriate activities in order 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, directly or indirectly, constructive working relationship with Health Authority contacts in the EU regionContribute to aggregate resource forecasting for the projects/products within the assigned early phase Oncology portfolioMentors, develops and coaches EU Regulatory Strategists/GRL(s) as applicable for projects within the designated early phase Oncology portfolio including aspects of performance management as appropriateSupports the EU Oncology Regulatory Strategy Leadership Team and drives the required culture and behaviors through the organizationChampions flexible approaches to ensure efficient and effective resource utilizationEnsures learning is embedded in the organizationOrganizational relationship Reports to EU Regulatory Strategy HeadSupervises EU regulatory strategists for the designated early phase Oncology portfolioPartners with GRLs/ Global head within early phase Oncology to ensure common understanding of issues and prioritiesWorks with GRS colleagues and relevant cross-functional 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, Medical and Commercial colleagues, to provide an EU positionWorks directly or indirectly with external contacts in Regulatory Agencies within EU region, as well as relevant experts and key opinion leadersEnsures alignment with GRL and GRPLQualification skills Advanced Scientific Degree (M.D, Ph.D, Pharm.D, M.Sc). or equivalent experience in drug, device, development and/or commercializationA business qualification (MBA) may be useful Proven business management capabilitiesDemonstrable experience in drug and/or device development or relevant experience in the Pharmaceutical industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Sciences/Health Authority and/or proven track record of success in negotiating with Health Authorities at EU regional level and in representing interests to internal and external stakeholdersRelevant Global regulatory experience (more than one region)Demonstrated strategic thinking and ability to integrate strategies into actionable plansProven ability to function autonomously at a senior level in a highly matrixed organizationHas significant experience of the oncology therapeutic area, through prior regulatory experience; direct product development and/or academic trainingProven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting CTAs, MAACommunication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior managementPresentation skills - Is effective in a variety of formal presentation settings; one- on-one, small and large groups, with peers, direct reports and senior managerNegotiation 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.
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 iscommitted to celebratingthis,in all itsforms – 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.
Regulatory Affairs#LI-PFE
About UsPfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
#J-18808-Ljbffr
