Safety & Labelling Partner Lead

hace 4 semanas

Madrid, España Norgine A tiempo completo

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's your passion for making a difference, focus on others' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people's wellness as much as you do.Because at Norgine, we transform lives with innovative healthcare solutions.We have an exciting opportunity for a Safety Labelling Partner Lead to join Norgine in any Norgine sites.
The person holding this position will report to Head of Global Labelling.The Safety Labelling Partner Lead provides strategic and operational labelling input and leads and oversees activities with the Regulatory Service Provider(s) to ensure the product labelling meets all applicable standards and regulations.If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.KEY RESPONSIBILITIES ACCOUNTABILITIESCreate and facilitate the meeting minutes at the Patient Safety Labelling Committee meeting.Manage QC checks of labelling documents following endorsement at Patient Safety Labelling Committee prior to approval by the Head of Global Labelling.Provide strategic labelling and operational regulatory input and work in close collaboration with Regulatory Service Provider(s) and Head of Global Labelling in maintaining compliant and competitive up to date labelling information, and track market specific variances in line with Norgine procedures.Manage the CCDS maintenance calendar.Interact with Regulatory Service Provider(s) to manage timely implementation of global labelling changes in national labels, ensuring international consistency and compliance with the CCDS.Chair of Safety Labelling Change Meeting, managing information flow for execution to Regulatory Service Provider(s).Oversee the approvals of core labelling documentation using Norgine systems to ensure transparency and accuracy of change.Responsible for the communication, check-up and oversight of regulatory submissions following updates to core labelling documentation in line with Norgine procedures.Work in an independent manner to ensure safety-related regulatory activities are planned, agreed and progressed so that procedural timeframes are met.Manage, track and update spreadsheets for labelling activities and generate metrics and report accordingly.Contribute to the Regulatory Service Provider(s) governance meetings by raising topics for resolution.Track and coordinate the progress of Regulatory Labelling Compliance activities (e.g.
deviations, CAPAs).Act as deputy for the Head of Global Labelling.Co-ordinate labelling queries and provide guidance on regulatory labelling requirements.Lead review of RMPs/PSURs activities.Contribute to the continuous improvement of the end to end labelling process, update Standard Operating Procedures, Work Instructions and supporting documents as required.Work with the Head of Global Labelling in regulatory labelling intelligence activities, including researching labelling across different markets and promoting best labelling practices.Regular management of reporting, ensuring data integrity is met and changes are on track for being delivered, resolve roadblocks proactively and escalate to the Head of Global Labelling where required.Oversee and contribute to the maintenance of all regulatory data in the relevant systems and tools in a timely manner for reporting and effectiveness checks.Requirements:Excellent verbal and written communication skills, especially suitable for labelling.Excellent interpersonal skills.Strong attention to detail required, especially for labelling revisions.Adaptable to change in business needs, proven ability to prioritise and organise plans.Work collaboratively and effectively both within RA, cross functionally and with external partners.Aspire to continuously develop technical/professional knowledge and interpersonal/management expertise.Fluency in English as a business language.Well-developed proven experience with EU and worldwide regulatory labelling requirements, and managing labelling submissions and related activities.Experience with global labelling processes and management of Company Core Data Sheets.Project and programme management experience.Working knowledge in safety label changes.Benefits vary between locations.Anti-discrimination and equal opportunities:Norgine prides itself on its integrity, honesty and fairness in all aspects of our business.
#J-18808-Ljbffr

  • Safety & Labelling Partner Lead

    hace 4 semanas

    Madrid, España Norgine A tiempo completo

    .At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's your passion for making a...

  • Safety & Labelling Partner Lead

    hace 4 semanas

    Madrid, España Norgine A tiempo completo

    .At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you're proud of, whether that's your passion for making a...

  • Safety & Labelling Partner Lead

    hace 1 semana

    Madrid, España Empresa Reconocida A tiempo completo

    .Want a 3D Career? Join Norgine. At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you're proud of, whether...

  • Safety & Labelling Partner Lead

    hace 3 días

    Madrid, España Empresa Reconocida A tiempo completo

    .Want a 3D Career?Join Norgine.At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's...

  • Safety & Labelling Partner Lead

    hace 7 meses

    Madrid, España Norgine A tiempo completo

    Want a 3D Career? Join Norgine. At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you’re proud of, whether...

  • Safety & Labelling Partner Lead

    hace 4 semanas

    Madrid, España Norgine A tiempo completo

    At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's your passion for making a...

  • Safety & Labelling Partner Lead

    hace 4 semanas

    Madrid, España Norgine A tiempo completo

    At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you’re proud of, whether that’s your passion for making a...

  • Safety & Labelling Partner Lead

    hace 4 semanas

    Madrid, España Norgine A tiempo completo

    At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you’re proud of, whether that’s your passion for making a...

  • Senior Regulatory Labelling Specialist

    hace 10 horas

    Madrid, Madrid, España Empresa Reconocida A tiempo completo

    Empresa Reconocida is a leading healthcare organisation that transforms lives with innovative solutions. We are seeking a talented individual to join our team as a Senior Regulatory Labelling Specialist in any of our sites.About the RoleThis is an exciting opportunity for a highly skilled and experienced professional to lead our labelling activities and...

  • Regulatory Labelling Expert

    hace 3 semanas

    Madrid, Madrid, España Norgine A tiempo completo

    Norgine offers a unique opportunity for an experienced Regulatory Labelling Expert to join their team in any of their locations worldwide. The successful candidate will report to the Head of Global Labelling and provide strategic and operational labelling input.The role involves leading and overseeing activities with regulatory service providers to ensure...

  • Regulatory Labelling Compliance Specialist

    hace 3 semanas

    Madrid, Madrid, España Norgine A tiempo completo

    At Norgine, we're committed to transforming lives with innovative healthcare solutions. We have an exciting opportunity for a Regulatory Labelling Compliance Specialist to join our team in a leading healthcare organisation.Navigating Complex RegulationsWe offer a fully-rounded experience with no limits, where you can bring your passion for making a...

  • Regulatory Labelling Expert

    hace 1 semana

    Madrid, Madrid, España Norgine A tiempo completo

    Norgine Overview">Norgine is a leading healthcare organisation dedicated to transforming lives with innovative healthcare solutions. Our company culture, known as the 3D career, encourages our colleagues to Dare to be different, Drive to achieve their goals, and Develop themselves and their community.">Job Summary">We are seeking a highly skilled Regulatory...

  • Labelling Compliance Specialist

    hace 3 semanas

    Madrid, Madrid, España Norgine A tiempo completo

    Norgine seeks a highly skilled Labelling Compliance Specialist to join their team in one of their locations. The ideal candidate will have excellent communication skills, attention to detail, and experience with regulatory labelling requirements.The role involves working closely with regulatory service providers to ensure product labelling meets all...

  • Global Regulatory Compliance Officer

    hace 3 semanas

    Madrid, Madrid, España Norgine A tiempo completo

    At Norgine, we strive to deliver innovative healthcare solutions that make a meaningful difference in people's lives. We're a company that cares deeply about our colleagues' growth and development, offering a fully-rounded experience with no limits. If you're passionate about creating a positive impact, focused on ensuring regulatory compliance, and driven...

  • Safety Engineering Lead

    hace 5 días

    Madrid, Madrid, España Tecnicas Reunidas A tiempo completo

    Tecnicas Reunidas, a leading Oil & Gas International Engineering and Construction Company, is seeking an experienced Senior Technical Safety/Technical Safety Lead. This challenging role involves developing and reviewing deliverables related to technical safety and environmental aspects.The ideal candidate will have a Bachelor of Engineering in Chemical...

  • Iberia Health, Wellness

    hace 3 días

    Madrid, España Mondelez International A tiempo completo

    Iberia Health, Wellness & Safety Lead Apply locations Madrid, Spain time type Full time posted on Posted 22 Days Ago job requisition id R-126210 Job Description Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It Possible. Our employees are key ingredients to our success, and you will balance...

  • Iberia Health, Wellness

    hace 3 semanas

    Madrid, España Mondelez International A tiempo completo

    .Iberia Health, Wellness & Safety Lead Apply locations Madrid, Spain time type Full time posted on Posted 2 Days Ago job requisition id R-126210 Job Description Are You Ready to Make It Happen at Mondelez International? Join our Mission to Lead the Future of Snacking. Make It Possible. Our employees are key ingredients to our success, and you will balance...

  • Global Program Safety Lead

    hace 3 meses

    Madrid, España Novartis A tiempo completo

    .Job Description Summary-Designs & develops safety surveillance strategy for products and approval. Responsible for the company's drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the...

  • Lead/senior Safety Officer

    hace 2 meses

    Madrid, España Pivotal A tiempo completo

    Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Lead/Senior Safety Officer who shares our vision of providing clinical research excellence. Joining Pivotal as a Lead/Senior Safety Officer, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a...

  • Medical Safety Portfolio Lead

    hace 3 semanas

    Madrid, Madrid, España Healthcare Businesswomen'S Association A tiempo completo

    Job SummarySandos seeks a seasoned Medical Safety Portfolio Lead to spearhead the strategic direction of our Medical Safety Team. As a key member of our organization, you will be responsible for leading a global team of medical professionals in ensuring the safety and efficacy of our products.About YouWe are looking for an exceptional leader with a strong...