Team Manager

Job Description

Position PurposeTo oversee and direct regional/national submission portfolio execution associated with ~40,000submissions worldwide to regulatory health authorities per annum, through leadership andengagement of Hub Submission Managers as part of a global business model.Executes strategic direction, defines and upholds regional submission standards in support of newregistrations and full product license lifecycle management to multiple regulatory authorities,maintaining compliance with applicable regulatory obligations while working to tight, businesscritical deadlines within a highly regulated environment.Accountable for managing submissions when required to meet business needs and at all timesmaintain a comprehensive and detailed oversight of process, quality control and regulatory workload within the function.Proactive coordination of load balancing, resources and training in support of cross regionalsubmission activity; assessment and monitoring of trends in portfolio activity that drive changes inoperating model.To represent Submissions Management as direct partner for GRA Country Regulatory Heads fordesignated markets and stakeholder management across partner linesPrimary ResponsibilitiesManagerPartnership with peers ensuring quality and consistency of processes, directly supervisingHub Submission Managers to ensure Pfizer delivers on key regulatory submission milestonesand maintains compliance with applicable regulatory obligationsResponsible for balancing workload within and across regions and resource optimization insupport of the global portfolioDrives and executes implementation of global submission policies and strategies to meetevolving business needs, achieving operational excellence through continuous improvementDevelops and executes the optimization and harmonization of hub process to support theflexible resourcing model, ensuring portfolio execution meets time, quality and budgetaryrequirementsServes as a major source of innovative ideas seeking efficiencies and effectiveness anddriving the implementation of technological solutionsUnderstands, interprets and influences technical requirements for electronic Submissions asdefined by FDA, EMA, MHLW, ICH and national marketsResponsible for developing partnerships with country/regional leads and key stakeholders toensure achievement of deliverables and identification of opportunities to gain greaterefficienciesResponsible for professional development through mentorship and motivation.Responsible for hub adherence to internal standards and maintains a state of InspectionReadinessProvides guidance to and leads moderately complex submission and process improvementprojects, making decisions independentlyLeads the interpretation of regulatory guidelines to produce business requirements and ensurethat those requirements are implemented where appropriate at local level.Manages own time to meet objectives; forecasts and plans resource requirements (people,financial and technology) for projects across DepartmentConsidered a technical resource within the groupMatrix manages global team efforts to ensure high quality components and submissions thatare compliantTechnical Skill RequirementsManagerDemonstrated business acumen; strong organizational management skills, the ability tomanage multiple demands simultaneously; the ability to respond to tight timelines in a highlyregulated environmentStrong knowledge of the drug development process, regulatory affairs, and submissionsmanagement; demonstrating an understanding of regional and national regulatory filingguidelines and dossier requirementsProven aptitude in project management and logisticsAbility to work on multiple highly complex projects simultaneously; demonstrated attentionto detail.In-depth understanding of systems and electronic technologies used to support submissionand planning activities, as well as demonstrated experiences in process development and newtechnology implementation.Strong understanding of build and delivery of human health electronic and paper regulatorysubmissions and electronic review aids as defined by FDA, EMA, MHLW and ICH.Ability to operate seamlessly and influence direct and indirect reports, as well as acrossorganizations.Ability to manage or deliver through others in a global operating modelAbility to manage a significant and diverse portfolio of work with cross-site and line teams.Proven ability to embrace new technologies and drive their implementationProven aptitude in project management and process re-designQualifications (i.e., preferred education, experience, attributes)B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable);equivalent relevant professional experience will be considered.Proven aptitude in project management and process redesignProven technical aptitude and ability to quickly learn and use new software, regulations andquality standardsDemonstrated excellence in interpersonal (verbal and written) skillsAbility to successfully establish and build collaborative relationships with colleagues within andacross an organizationDemonstrated leadership and flexibility in dealing with change and diversity as part of a globalteamExperience in resource management in a professional & dynamic environmentMulti-lingual skills desirable.Familiarity with pharmaceutical organizational structures, systems, and culture is preferredPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs #LI-PFE,

Keyskills :
slacustomer relationscoachingcustomer servicesalesequal employment opportunitylife sciencesload balancingquality controlbusiness acumendrug developmentmanagement skillsproject managementstatements of work sow