Regulatory Affairs Manager, Quality Assurance and Compliance - Italy Apply locations: Italy | Remote | Time type: Full time | Posted on: Posted Yesterday | Job requisition id: R27429
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 local support on these matters.
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 ItalySupport the local direction of the Department to guarantee permanent alignment with EU and local regulatory legislation and company rules.Maintain fluent interactions with local stakeholders in Italy including MoH authorities, Italy Medicine Agency, and Infarmed.Participate 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 provide responses to regulatory authorities to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.Perform the local review and approval of promotional and non-promotional materials used in Italy and submit to authorities where applicable, in alignment with 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 ItalySupport the function in Italy to build up a local quality management system as required by local regulations.Perform review and approval of local customers.Support the local director of the department for product complaints, product recalls, deviations, change controls, destructions, returns, mock-recalls, and serialization matters.Collaborate to develop, maintain, and validate standard operating procedures or local working practices, and ensure compliance.Collaborate in local quality agreements with the LSP.Participation and Contribution in Local Compliance Activities for ItalyCollaborate in the local development of processes and procedures needed.Participate in local industry working group meetings.Collaborate in training new starters in alignment with local Codes and Company rules.Contribute to the annual live Monitoring and Auditing exercise on local activities, as per Monitoring and Auditing checklist.Collaborate in compliance advice for local and international events in Italy.Education Required: University degree in life science / pharmacy.
5+ years of experience in the pharmaceutical industry. Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.
Other 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 Competencies: When 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.
About Us: BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.
With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.
We are committed to radically improving access to medicines for far more patients who need them.
Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).
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