Eu&Int Regulatory Affair Manager

4 settimane fa

Ancona, Italia Altro A tempo pieno

On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for a EU & INT Regulatory Affair Manager who can join an exciting working environment in a dynamic atmosphere.RESPONSIBILITIESDevelop regulatory strategies for the Emerging Markets countries to meet Chiesi Global Rare Diseases Regulatory Affairs relevant objectives, with regional Head limited supervisionIn collaboration with consultants, partners and affiliates, plan, coordinate and manage regulatory submissions to regional agencies throughout the life cycle of GRD productsIn full alignment with the regional Head, provide advice and guidance regarding regional regulatory requirements driving the development and geographical expansion of GRD products.Contribute to the preparation and / or review of submissions to relevant markets to ensure the high quality of the documentationIn agreement with the regional Head, communicate directly with regional regulatory authorities on behalf of Chiesi GRD to negotiate strategies and actions associated with regulatory submissionsCritically review regulatory submission documents, periodic updates, overviews, summaries, etc., make recommendations for improvement and ensure adequacy for submission.Contributes to the development of processes and the preparation of Standard Operating Documents for GRD Regulatory AffairsIn full alignment with the regional Head, provide regulatory guidance to colleagues from other functional areasProvide regulatory expertise in support of due diligence assessmentsRepresent the Regulatory Department at the Core Team as a global RA member, where neededSupport the Regional GRD Regulatory Affairs Head in the preparation of the needed documents for the meetings and interactions with regional regulatory authoritiesREQUIREMENTS AND SKILLSExperience required: 3 to 5 years of experience in corporate regulatory affairs roles with an in-depth knowledge in the drug developmentEducation: Life Science DegreesTechnical Skills: good levelSoft Skills:flexible, collaborative, open mindedWell-developed written and oral communication and listening skillsWell-developed time management skills and demonstrated ability to manage complex assignments.Experience in leadership and coaching is an asset.Well-developed analytical and problem-solving skills.Ability to work independently and as part of a team.TYPE OF CONTRACTChemical ContractIQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into#J-18808-Ljbffr

  • Eu&Int Regulatory Affair Manager

    3 settimane fa

    Ancona, Italia Iqvia Italia A tempo pieno

    On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for a EU & INT Regulatory Affair Manager who can join an exciting working environment in a dynamic atmosphere....

  • Eu&Int Regulatory Affair Manager

    3 settimane fa

    Ancona, Italia Altro A tempo pieno

    On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for a EU & INT Regulatory Affair Manager who can join an exciting working environment in a dynamic...

  • Scheme Manager

    2 settimane fa

    Ancona, Italia Certexe A tempo pieno

    About the RoleCertexe is a new independent organization aiming to provide high-quality conformity assessment, certification, and regulatory support services for medical devices and related technologies.The company is actively pursuing Notified Body accreditation under Regulation (EU) ******** (MDR), with a mission to ensure safety, innovation, and compliance...

  • STORE MANAGER GDO

    1 settimana fa

    Ancona, Italia Randstad Italia Spa A tempo pieno

    Mansione Sei pronto a guidare un team verso il successo e a gestire un punto vendita in completa autonomia? Entra in una realt solida e in continua crescita che valorizza le persone e investe sul loro futuro. Randstad Talent Selection è la specialty che si occupa di Ricerca &, Selezione di professionisti qualificati. Per un'importante azienda cliente...

  • Site manager

    4 settimane fa

    Ancona, Italia Altro A tempo pieno

    OverviewRenco S.p.A. is a leading international engineering and construction firm with over 40 years' experience. We deliver innovative, sustainable solutions, prioritizing collaboration, technology, and a diverse, inclusive workplace. We're dedicated to a better future, fostering talent through professional growth opportunities. Join us to "live the planet...

  • Italian speaking E2E Manager €180 per day

    4 settimane fa

    Ancona, Italia Altro A tempo pieno

    Italian speaking E2E Manager Location: AnconaPay: €180 per dayContract: 1 year fixedClient AxiaMetricsJob Description We are seeking an experienced E2E Technical Manager with extensive knowledge of Fixed IMS and Metaswitch. The role involves overseeing end‑to‑end technical management of our IMS solutions, ensuring optimal performance and...

  • Employee Relations Lead

    3 settimane fa

    Ancona, Italia Amazon A tempo pieno

    A global e-commerce leader seeks an ER Manager for its Italy operations, based in Ancona, to drive employee relations and compliance. This full-time position requires strong analytical and interpersonal skills, with a focus on cultivating relationships with stakeholders. Ideal candidates will have a Master's degree in Human Resources or a related field and...

  • Employee Relations Lead

    3 settimane fa

    Ancona, Italia Amazon A tempo pieno

    A global e-commerce leader seeks an ER Manager for its Italy operations, based in Ancona, to drive employee relations and compliance. This full-time position requires strong analytical and interpersonal skills, with a focus on cultivating relationships with stakeholders. Ideal candidates will have a Master's degree in Human Resources or a related field and...

  • Hse Manager

    2 settimane fa

    Ancona, Italia Piper Maddox A tempo pieno

    The CompanyA global energy and industrial group driving the transition to a low-carbon future.The business operates across multiple continents, delivering major renewable, industrial, and green metallurgy projects.With thousands of employees and multi-billion turnover, the company invests heavily in innovation, cutting-edge technology, and long-term...

  • Business Development Manager

    2 settimane fa

    Ancona, Italia Pylontech A tempo pieno

    Company OverviewPylontech is a leading global provider of Battery Energy Storage Systems (BESS), renowned for its innovative solutions in the energy storage sector.Established in **** and headquartered in Shanghai, China, Pylontech has become a prominent player in the industry, delivering over 4.5 GWh of energy storage capacity across more than 80...