Manager Regulatory Affairs, Quality Assurance And Compliance Spain

hace 7 días

Alcobendas, España Beigene A tiempo completo

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 Spain and Portugal, this position will provide with local support on these matters.
-Collaboration in the technical activities of these areas in Spain and Portugal 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 Spain and Portugal.Support the local direction of the Department to guarantee permanent alignment with EU and local regulatory legislation and company rules.Ability to keep fluent interactions with local stakeholders in Spain and Portugal including MoH authorities, Spanish Medicine Agency and Infarmed.Participation in the regulatory review and approval of local versions of SmPC, labels and package leaflets and prepare and review information to include on promotional materials.Contribute to the preparation and submission of local regulatory agency applications and reports and to provide response to regulatory authorities matters to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.Perform the local review and approval of promotional and non-promotional materials used in Spain and Portugal and submission to authorities where applicable, in alignment to Farmaindustria and Apifarma Codes and company rules.Responsible for the implementation of the approved labels and PL changes in the commercial artworks.Participation and contribution in local Quality Assurance activities for Spain and Portugal.Support the function in Spain and Portugal to build up a local quality management system as required by local regulations.Perform review, and approval of local customers.Support local director of the department for product complaints, product recalls, deviations, change controls, destructions, returns, mock-recalls and serialization matters.Collaboration to develop, maintain, and validate standard operating procedures or local working practices, and ensure compliance.Collaboration in local quality agreement with the LSP.Participation and contribution in local Compliance activities for Spain and Portugal.Collaboration in local development of processes and procedures needed.
-Participation in local industry working group meetings.Collaboration in trainings to new starters in alignment to local Codes and Company rules.Contribution on annual live Monitoring and Auditing exercise on local activities, as per Monitoring and Auditing checklist.Collaboration in the compliance advice for local and international events in Spain and Portugal.Education Required:University degree in life science / pharmacy5+ years of experience in the pharmaceutical industryComputer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and OutlookOther Qualifications:Ability to work effectively in a fast-paced environment.Good interpersonal and collaborative skills, strong organizational skills and effective written and verbal communication skills.Travel: 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 Clarity

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