Lavori attuali relativi a Labelling and Regulatory Compliance Expert - Milano, Lombardia - PharmaLex

  • Regulatory Affairs Specialist

    4 settimane fa

    Milano, Lombardia, Italia PharmaLex A tempo pieno

    About the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at PharmaLex. As a Regulatory Affairs Specialist, you will be responsible for managing the preparation and revision of informative texts for healthcare professionals and patients, as well as ensuring compliance with regulatory requirements.Your...

  • Compliance and Sustainability Expert

    2 giorni fa

    Milano, Lombardia, Italia Human Value S.R.L. A tempo pieno

    Job Description:As a Compliance and Sustainability Expert at Human Value S.R.L., you will oversee the company's compliance systems, ensuring adherence to regulatory frameworks and organizational policies. Your role will involve liaising with internal departments to ensure data flow and compliance throughout the value chain.Key Responsibilities:Develop and...

  • Regulatory Affairs Specialist

    2 settimane fa

    Milano, Lombardia, Italia Lights On Women (Low) A tempo pieno

    Job Title: Regulatory Affairs Specialist - EU Compliance ExpertJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lights On Women (Low). The successful candidate will be responsible for monitoring the evolution of the regulatory context within the EU, particularly in the gas distribution market, and ensuring the...

  • Regulatory Affairs Expert

    2 mesi fa

    Milano, Lombardia, Italia CooperCompanies A tempo pieno

    About the RoleWe are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team at CooperCompanies. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key ResponsibilitiesRegulatory Support and Guidance: Provide...

  • Regulatory Compliance Expert

    4 giorni fa

    Milano, Lombardia, Italia Saxo Bank A tempo pieno

    Milan, ItalyAbout the RoleAs a Compliance & AML Specialist at Saxo Bank, you will play a vital role in supporting the business in meeting regulatory requirements in an international environment. The Compliance and AML function is responsible for assessing compliance and AML risks, providing advisory and monitoring activities, assisting with reporting, and...

  • Compliance and AML Expert

    6 giorni fa

    Milano, Lombardia, Italia Allianz Popular Sl. A tempo pieno

    Job DescriptionAllianz Bank Financial Advisors, the financial arm of the Allianz Group in Italy, seeks a highly skilled professional to oversee regulatory and reputational risks. As the Head of Compliance and AML, you will play a crucial role in ensuring the company's adherence to Italian and European legislation.Key ResponsibilitiesLegislative...

  • Regulatory Compliance Expert

    6 giorni fa

    Milano, Lombardia, Italia Fabrick A tempo pieno

    Fabrick is a pioneering Open Finance Platform that seamlessly integrates Open Banking and Open Payments services, leveraging an ecosystem of innovative fintechs.We are seeking a highly skilled Compliance Specialist to join our Compliance & AML Team.The ideal candidate will be responsible for overseeing and managing compliance activities for Fabrick and its...

  • Compliance Officer

    2 settimane fa

    Milano, Lombardia, Italia Infront Sports & Media Group A tempo pieno

    Job SummaryWe are seeking a Compliance Officer to join our team at Infront Sports & Media Group. As a Compliance Officer, you will be responsible for ensuring that our business practices align with our corporate standards and regulatory requirements.Key ResponsibilitiesRaise awareness of compliance issues among employees and managementImplement and maintain...

  • Senior Regulatory Expert

    2 settimane fa

    Milano, Lombardia, Italia Be Group A tempo pieno

    Be Group: A Leader in Management Consultancy and Digital EngagementBe Group is a leading player in the Italian market for Management Consultancy and Digital Engagement. With over 1,600 employees and offices in 9 countries, we operate in the Capital Markets, Banking, Payments, and Digital Finance sectors.We are seeking a Senior Consultant to join our team and...

  • Compliance Quality Assurance Senior Expert

    3 settimane fa

    Milano, Lombardia, Italia Ing Bank N.V. A tempo pieno

    Job DescriptionAs a Compliance Quality Assurance Senior Expert at ING Bank N.V., you will play a crucial role in ensuring the quality of our compliance processes and controls. Your primary responsibility will be to design, implement, and maintain effective compliance programs that mitigate risks and ensure regulatory compliance.Key Responsibilities:Develop...

  • Risk and Compliance Expert

    2 settimane fa

    Milano, Lombardia, Italia ION A tempo pieno

    Job SummaryWe are seeking a highly skilled Governance, Risk and Compliance Analyst to join our team at ION. As a key member of our Governance, Risk and Compliance Team, you will play a critical role in supporting the management of information security and associated controls, risk management, and compliance with relevant control standards, regulation, and...

  • Compliance Expert

    2 settimane fa

    Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    O n behalf of our client - a global pharma company - we are seeking a Compliance Expert to join our Group Compliance & Ethics department. The Compliance Expert will actively contribute to the development of our Group compliance framework, which includes the implementation and execution of a comprehensive compliance monitoring program. Key Responsibilities: ...

  • Compliance Quality Assurance Senior Expert

    2 settimane fa

    Milano, Lombardia, Italia ING A tempo pieno

    Job Title: Compliance Quality Assurance Senior ExpertJob Summary:ING is seeking a highly experienced Compliance Quality Assurance Senior Expert to join our team. As a key member of our Compliance Quality Assurance Team, you will be responsible for ensuring the quality of our compliance processes and controls.Key Responsibilities:Perform quality assurance...

  • Audit and Compliance Expert

    3 giorni fa

    Milano, Lombardia, Italia Société Générale Assurances A tempo pieno

    Senior Auditor Job DescriptionThe Senior Auditor will play a crucial role in ensuring the integrity of our financial operations and compliance with regulatory requirements.Responsibilities:Identify and assess risks in our financial processes and systems.Conduct audits and reviews to ensure compliance with regulatory requirements and company policies.Develop...

  • Regulatory Compliance Specialist

    2 settimane fa

    Milano, Lombardia, Italia Euronext A tempo pieno

    We are seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to join our team at Euronext. The ideal candidate will have a Master's Degree in Law and excellent knowledge of English. The role involves updating, verifying, and monitoring internal consistency of the Rules of Borsa Italiana, MTS, Cassa di Compensazione e Garanzia, and...

  • Regulatory Affairs Expert

    12 ore fa

    Milano, Lombardia, Italia The Kraft Heinz Company A tempo pieno

    Job Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at The Kraft Heinz Company. As a Regulatory Affairs Manager, you will be responsible for ensuring all product labels used by Kraft Heinz in Europe comply with food legislation, government guidelines, and company policies, with a...

  • Regulatory Compliance Specialist

    2 settimane fa

    Milano, Lombardia, Italia 0896 Deutsche Bank Società per Azioni A tempo pieno

    Job SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at 0896 Deutsche Bank Società per Azioni. The successful candidate will be responsible for supporting the Head of Central Compliance Italy in managing country regulatory relationships, ensuring timely and effective communication with local and global regulators.Main...

  • Central Compliance and Regulatory Management Specialist

    4 settimane fa

    Milano, Lombardia, Italia 0896 Deutsche Bank Società per Azioni A tempo pieno

    Job Title: Central Compliance and Regulatory Management SpecialistDescription:The Compliance Italy team at Deutsche Bank Società per Azioni is seeking a Central Compliance and Regulatory Management specialist to join their team. The successful candidate will support the team in managing interactions with local and global regulators, reporting to the Head of...

  • Central Compliance and Regulatory Management Specialist

    1 mese fa

    Milano, Lombardia, Italia 0896 Deutsche Bank Società per Azioni A tempo pieno

    Job Title: Central Compliance and Regulatory Management SpecialistDescription:The Compliance Italy team at Deutsche Bank Società per Azioni is seeking a Central Compliance and Regulatory Management specialist to join their team. The successful candidate will support the team in managing interactions with local and global regulators, reporting to the Head of...

  • Regulatory Compliance Manager

    4 giorni fa

    Milano, Lombardia, Italia 0896 Deutsche Bank Società per Azioni A tempo pieno

    Job SummaryThe Central Compliance and Regulatory Management Specialist will support the team in managing interactions with local and global regulators and report to the Head of Central Compliance Italy.Main ResponsibilitiesSupport the Head of Central Compliance Italy in managing country regulatory relationships, ensuring proper support and escalations.Ensure...

Labelling and Regulatory Compliance Expert

2 mesi fa

Milano, Lombardia, Italia PharmaLex A tempo pieno
Job Title: Regulatory Affairs Specialist - Labelling

We are seeking a highly skilled Regulatory Affairs Specialist - Labelling to join our team at PharmaLex, a leading provider of regulatory affairs and labelling services. In this role, you will be responsible for ensuring the accuracy and compliance of labelling documentation for pharmaceutical products.

Key Responsibilities:
  • Informative Text Preparation: Participate in the preparation and revision of informative texts for healthcare professionals and patients, including SmPC, PIL, and Labelling.
  • CCDS/CCSI/RSI Management: Manage the creation and maintenance of CCDS/CCSI/RSI, collaborating with relevant departments and expert functions.
  • Communication and Escalation: Communicate new and updated CCDSs to internal and external stakeholders, and escalate deviation and compliance issues to labelling governance bodies as necessary.
  • Regulatory Affairs and Development Consulting: Ensure regulatory affairs, development consulting, and scientific affairs programs and projects are delivered to high standards.
  • Project Planning and Execution: Plan and expedite approval projects using internal or client-based software tools.
  • Regulatory Expertise: Provide regulatory expertise to regulatory programs and projects, as well as to clients.
  • General Guidance and Support: Offer general guidance on Regulatory Submissions & Labelling activities, including updates on new trends and changes in legislation.
  • Presentation and Training: Present seminars and lectures on behalf of PharmaLex internally, for customers, and for professional audiences.
  • Regulatory Documentation: Create, revise, edit, and maintain regulatory documentation.
  • Client and Health Authority Interaction: Interact professionally with clients and Health Authorities.
  • Project Team Coordination: Coordinate project teams with internal and external staff and Regulatory Alliance Partners worldwide.
  • Strategic Regulatory Issues: Participate in strategic regulatory issues, including defining suitable methods of resolution.
  • Business Development Support: Provide technical support to business development, focusing on Labelling activities and adjacent areas on EU and global levels.
Requirements:
  • Language Skills: Fluent business English (English is your mother tongue) and preferably another EU language.
  • Education: Completed degree in pharmacy, medicine, or other life sciences, or a bachelor's degree in science, engineering, or mathematical domain.
  • Professional Experience: Professional experience in regulatory affairs with a strong track record in labelling activities for innovator drugs on a global level.
  • Marketing Authorization Experience: Experience in handling marketing authorizations and their lifecycle management.
  • Regulatory Knowledge: Sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region.
  • Technical Skills: Affinity for databases, labelling software tools, and project management software, with a focus on monitoring and adhering to timelines.
  • Soft Skills: Team player with excellent communication, conscientious, accurate, and responsible skills.
  • Software Proficiency: Confident with MS Excel, MS Word, databases, and document management systems.
What We Offer:
  • Diverse and Challenging Job: A diverse and challenging job that will keep you engaged and motivated.
  • Open and Appreciative Corporate Culture: An open and appreciative corporate culture that values teamwork and collaboration.
  • Flexible Working Hours: Flexible working hours based on trust, allowing you to balance your work and personal life.
  • Reduced Working Hours: Possibility to work a reduced number of hours, depending on your needs and preferences.
  • Remote Work: Possibility to work from home, depending on the needs of the company and the role.
  • Continuous Development Opportunities: Continuous development opportunities through knowledge and experience, as well as training and professional growth.