Regulatory Affairs Specialist

2 settimane fa

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

PharmaLex is seeking a highly skilled Regulatory Affairs Specialist - Labelling to join our team. In this role, you will be responsible for ensuring the accuracy and compliance of labelling documentation for pharmaceutical products.

Key Responsibilities:
  • Participate in the preparation and revision of informative texts for healthcare professionals and patients, including SmPC, PIL, and Labelling.
  • Manage the creation and maintenance of CCDS/CCSI/RSI, collaborating with relevant departments and expert functions.
  • Communicate new and updated CCDSs to internal and external stakeholders.
  • Escalate deviation and compliance issues to labelling governance bodies as necessary.
  • Ensure regulatory affairs, development consulting, and scientific affairs programs and projects are delivered to high standards.
  • Plan and expedite approval projects using internal or client-based software tools.
  • Provide regulatory expertise to regulatory programs and projects, as well as to clients.
  • Offer general guidance on Regulatory Submissions & Labelling activities, including updates on new trends and changes in legislation.
  • Present seminars and lectures on behalf of PharmaLex internally, for customers, and for professional audiences.
  • Create, revise, edit, and maintain regulatory documentation.
  • Interact professionally with clients and Health Authorities.
  • Coordinate project teams with internal and external staff and Regulatory Alliance Partners worldwide.
  • Participate in strategic regulatory issues, including defining suitable methods of resolution.
  • Provide technical support to business development, focusing on Labelling activities and adjacent areas on EU and global levels.
Requirements:
  • Fluent business English (English is your mother tongue) and preferably another EU language.
  • Completed degree in pharmacy, medicine, or other life sciences, or a bachelor's degree in science, engineering, or mathematical domain.
  • Professional experience in regulatory affairs with a strong track record in labelling activities for innovator drugs on a global level.
  • Experience in handling marketing authorizations and their lifecycle management.
  • Sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region.
  • Affinity for databases, labelling software tools, and project management software, with a focus on monitoring and adhering to timelines.
  • Team player with excellent communication, conscientious, accurate, and responsible skills.
  • Confident with MS Excel, MS Word, databases, and document management systems.
What We Offer:
  • A diverse and challenging job with opportunities for growth and development.
  • An open and appreciative corporate culture that values teamwork and collaboration.
  • Flexible working hours based on trust, allowing for a healthy work-life balance.
  • The possibility to work a reduced number of hours or from home, promoting flexibility and work-life balance.
  • Continuous development opportunities through knowledge and experience, as well as training and professional development.

  • Regulatory Affairs Specialist

    7 giorni fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Page Personnel. As a key member of our regulatory team, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.Main ResponsibilitiesManage and prepare regulatory dossiers (CTD)...

  • Regulatory Affairs Specialist

    1 settimana fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Page Personnel. As a key member of our regulatory team, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.Main ResponsibilitiesManage and prepare regulatory dossiers (CTD)...

  • Regulatory Affairs Specialist

    1 giorno fa

    Milano, Lombardia, Italia PharmaLex A tempo pieno

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at PharmaLex. As a key member of our team, you will be responsible for managing the creation and maintenance of labelling and regulatory documentation for our clients.Key ResponsibilitiesParticipate in the preparation and revision of labelling and regulatory...

  • Regulatory Affairs Specialist

    1 settimana fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    About the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Page Personnel. As a key member of our team, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.Main Responsibilities:Managing and preparation of regulatory dossier...

  • Senior Regulatory Affairs Specialist

    7 giorni 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...

  • Senior Regulatory Affairs Specialist

    1 settimana 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 Affairs Specialist

    7 giorni fa

    Milano, Lombardia, Italia PharmaLex A tempo pieno

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at PharmaLex. As a key member of our team, 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.Key ResponsibilitiesParticipate in...

  • Regulatory Affairs Specialist

    1 settimana fa

    Milano, Lombardia, Italia PharmaLex A tempo pieno

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at PharmaLex. As a key member of our team, 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.Key ResponsibilitiesParticipate in...

  • Regulatory Affairs Specialist

    6 giorni fa

    Milano, Lombardia, Italia Meet Recruitment Limited A tempo pieno

    Job DescriptionMeet Recruitment Limited is seeking a highly skilled Regulatory Affairs Associate to join our team.Key Responsibilities:Assist in the preparation and submission of regulatory documents to regulatory agencies, ensuring compliance with applicable regulations and standards.Prepare submissions of license variations, notifications, and renewals to...

  • Regulatory Affairs Specialist

    1 settimana fa

    Milano, Lombardia, Italia Meet Recruitment Limited A tempo pieno

    Job DescriptionMeet Recruitment Limited is seeking a highly skilled Regulatory Affairs Associate to join our team.Key Responsibilities:Assist in the preparation and submission of regulatory documents to regulatory agencies, ensuring compliance with applicable regulations and standards.Prepare submissions of license variations, notifications, and renewals to...

  • Regulatory Affairs Expert

    1 settimana 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 Affairs Expert

    6 giorni 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 Affairs Coordinator

    7 giorni fa

    Milano, Lombardia, Italia Meet Recruitment Limited A tempo pieno

    Job DescriptionMeet Recruitment Limited is seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our Regulatory Affairs department, you will play a crucial role in ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Regulatory Document Preparation: Assist in the preparation and submission...

  • Regulatory Affairs Coordinator

    1 settimana fa

    Milano, Lombardia, Italia Meet Recruitment Limited A tempo pieno

    Job DescriptionMeet Recruitment Limited is seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our Regulatory Affairs department, you will play a crucial role in ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Regulatory Document Preparation: Assist in the preparation and submission...

  • Regulatory Affairs Expert in Medical Devices

    4 settimane fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    We are looking for a dedicated and detail-focused Regulatory Affairs Expert to contribute to our operations. This role is essential in ensuring adherence to regulatory standards for our medical devices. The selected candidate will work collaboratively with various internal teams to facilitate product development, registration, and compliance activities...

  • International Regulatory Affairs Manager

    3 giorni fa

    Milano, Lombardia, Italia Pharma Point Srl A tempo pieno

    Job Title: International Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled International Regulatory Affairs Manager to join our team at Pharma Point Srl. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with international regulatory requirements and supporting the company's growth in...

  • Regulatory Affairs Specialist

    1 settimana fa

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

    Job SummaryThe Kraft Heinz Company is seeking a highly skilled Regulatory Affairs Manager to join our team in Milan. As a key member of our Legal, Government and Regulatory department, you will be responsible for ensuring compliance with food legislation, government guidelines, and company policies.Main ResponsibilitiesEnsure all product labels used by Kraft...

  • Labelling and Regulatory Compliance Expert

    7 giorni fa

    Milano, Lombardia, Italia PharmaLex A tempo pieno

    Job Title: Regulatory Affairs Specialist - LabellingWe 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...

  • Labelling and Regulatory Compliance Expert

    2 settimane fa

    Milano, Lombardia, Italia PharmaLex A tempo pieno

    Job Title: Regulatory Affairs Specialist - LabellingWe 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...

  • Senior Regulatory Compliance Specialist

    7 giorni fa

    Milano, Lombardia, Italia Ortho Clinical Diagnostics A tempo pieno

    About the RoleWe are seeking a highly skilled Senior Regulatory Compliance Specialist to join our team at Ortho Clinical Diagnostics. As a key member of our regulatory affairs team, you will be responsible for ensuring conformity of regulatory processes and strategies to local and international regulations as well as company standards.Key...