Eu&Int Regulatory Affair Manager
4 settimane fa
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 aEU & INT Regulatory Affair Manager who can join an exciting working environment in a dynamic atmosphere. RESPONSIBILITIES : Develop regulatory strategies for the Emerging Markets countries to meet Chiesi Global Rare Diseases Regulatory Affairs relevant objectives, with regional Head limited supervision In collaboration with consultants, partners and affiliates, plan, coordinate and manage regulatory submissions to regional agencies throughout the life cycle of GRD products In 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 documentation In 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 Critically 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 Affairs In full alignment with the regional Head, provide regulatory guidance to colleagues from other functional areas Provide regulatory expertise in support of due diligence assessments Represent the Regulatory Department at the Core Team as a global RA member, where needed Support the Regional GRD Regulatory Affairs Head in the preparation of the needed documents for the meetings and interactions with regional regulatory authoritiesREQUIREMENTS AND SKILLS : Experience required 3 to 5 years of experience in corporate regulatory affairs roles with an in-depth knowledge in the drug development EducationLife Science Degrees Technical Skills good level Soft Skills : flexible, collaborative, open minded Well-developed written and oral communication and listening skills Well-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 CONTRACT : Chemical Contract IQVIA 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
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