BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.
When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:Under the guidance of the local Director Regulatory Affairs, Quality Assurance and Compliance for Italy, this position will provide with local support on these matters.
-Collaboration in the technical activities of these areas in Italy across BeiGene's portfolio and throughout the clinical development and post-marketing phases of the life cycle.
-This job description provides the broadest description of potential assigned activities for this role at BeiGene.Essential Functions of the job:Participation and contribution in local Regulatory Affairs activities for ItalyManage regulatory activities for BeiGene's portfolio through the entire products life cycleManage operations related to new product launches and extension of indicationsReview and approval of local version of product information and artworksManage Italian Regulatory Authority Database and update of external DatabasesManage regulatory communications to AuthoritiesWork with EU Functions and external Partner on Bollini/serializationProvide regulatory guidance and procedures for ensuring regulatory compliance to departments or development project teams regarding design, development, evaluation, or marketing of productsCommunicate regulatory information to multiple departments (Medical, Market Access, Customer Engagement etc.)
and ensure that information is interpreted correctly within the affiliateProvide regulatory review and approval of local promotional and non-promotional materials used in ItalyReview all national regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standardsMonitor national and international legislation and perform an impact assessment where neededMonitor local regulatory affairs trends that are related to environmental issuesSupport the implementation of additional risk minimization measures and of safety label updates in ItalyFormulate or implement local regulatory affairs/scientific service policies and procedures to ensure that regulatory compliance is maintained or enhancedTrain new starters and provide refresher training to relevant staff, in particular field force about regulatory matters, scientific service matters and internal processes.Participation and contribution in local Compliance activities for ItalySupport direct Manager in adapt, customize, maintain and validate local standard operating procedures or local working practices based on Global HCC Manual and local laws and Codes requirementsSupport Sunshine Act Transparency reporting process implementation and monitoringSupport direct Manager in managing internal monitoring and tracking deviationsQualifications:University degree in life science / pharmacy5+ years of experience in the pharmaceutical industryEfficient in Microsoft Word, Excel, MS Project, MS PowerPoint and OutlookAbility to work effectively in a fast-paced environment.Good interpersonal and collaborative skills, strong organizational skills and effective written and verbal communication skills.Fluent English - Oral and writtenTravel: up to 10%BeiGene Global CompetenciesWhen we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityWe are proud to be an equal opportunity employer and we value diversity.
BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.
All employment is decided on the basis of qualifications, merit, and business need.SummaryLocation: Italy RemoteType: Full time