POn 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 bEUINT Regulatory Affair Manager /bwho can join an exciting working environment in a dynamic atmosphere. /ppbr/ppbRESPONSIBILITIES: /b /pulliDevelop regulatory strategies for the Emerging Markets countries to meet Chiesi Global Rare Diseases Regulatory Affairs relevant objectives, with regional Head limited supervision /liliIn collaboration with consultants, partners and affiliates, plan, coordinate and manage regulatory submissions to regional agencies throughout the life cycle of GRD products /liliIn full alignment with the regional Head, provide advice and guidance regarding regional regulatory requirements driving the development and geographical expansion of GRD products. /liliContribute to the preparation and/or review of submissions to relevant markets to ensure the high quality of the documentation /liliIn agreement with the regional Head, communicate directly with regional regulatory authorities on behalf of Chiesi GRD to negotiate strategies and actions associated with regulatory submissions /liliCritically review regulatory submission documents, periodic updates, overviews, summaries, etc., make recommendations for improvement and ensure adequacy for submission. /liliContributes to the development of processes and the preparation of Standard Operating Documents for GRD Regulatory Affairs /liliIn full alignment with the regional Head, provide regulatory guidance to colleagues from other functional areas /liliProvide regulatory expertise in support of due diligence assessments /liliRepresent the Regulatory Department at the Core Team as a global RA member, where needed /liliSupport the Regional GRD Regulatory Affairs Head in the preparation of the needed documents for the meetings and interactions with regional regulatory authorities /li /ulpbr/ppbREQUIREMENTS AND SKILLS: /b /pullibExperience required /b: 3 to 5 years of experience in corporate regulatory affairs roles with an in-depth knowledge in the drug /li /ulpdevelopment /pullibEducation /b: Life Science Degrees /lilibTechnical Skills /b : good level /lilibSoft Skills : /b /liliflexible, collaborative, open minded /liliWell-developed written and oral communication and listening skills /liliWell-developed time management skills and demonstrated ability to manage complex assignments. /liliExperience in leadership and coaching is an asset. /liliWell-developed analytical and problem-solving skills. /liliAbility to work independently and as part of a team. /li /ulpbr/ppbTYPE OF CONTRACT: /b /ppChemical Contract /ppbr/ppbr/ppIQVIA 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 account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77). /p