regulatory affairs project manager europe

EU REGION LEADERSHIP * Ensures regulatory coordination for dossiers and tracks actions required for submissions in EU in accordance with plans * Contributes to Therapeutic Area Team regulatory strategy for specific projects, in particular ensures that the needs for his/her region are adequately reflected * Guides the preparation of regulatory activities with relevant functions of Project Teams and EU local group according to the strategy validated * Supervises critical and constructive review of regulatory projects * VALIDATE LOCAL TIMELINES FOR FILLING AND APPROVAL USED INTO COUNTRY 5Y PLANS AND PROVIDE VISIBILITY TO LRA WITH ALL REGISTRATION MATERIALS (including for renewals and variations) FROM GLOBAL IN SUPPORT OF THESE TIMELINES * ENSURE THAT ALL GLOBAL CONTRIBUTORS (GRA TAs, Clinical Development, R&D Medical, GMA, PK, GPS, …) AND OTHER CONTRIBUTORS OUTSIDE R&D (E.G. CMC REG) Are aligned with such timelines, allocate corresponding resources, commit to deliver required materials in due time * MONITOR LOCAL REGULATORY ROADMAP IMPLEMENTATION (registration, maintenance & variations) * Ensures adequate planning. Identifies appropriate internal or external resources when needed * When needed coordinates EU procedures with support from TA and Local Regulatory Affairs (LRA) * Coordinates the regulatory agencies consultations * Helps timely dissemination of questions from authorities to the relevant functions and stakeholders, and the coordination of related responses * Ensures adequate coordination of regulatory activities through reliable liaison with LRAs. Maintains a continuous flow of information with LRAs depending on the progress of projects * Ensures EU/LRA officer feedback of local HTA/market/business requirements during the course of product development in order to facilitate future market access COMPLIANCE * Ensures regulatory dossiers drawn up according to regulatory standards * Ensures consistency between local registration plans and manufacturing plans. Operates according to Regulatory and Ipsen SOPs REGULATORY INTELLIGENCE * Provide to Regulatory intelligence, by tracking and analysing the evolution of regulations relating to his/her areas * Informs the relevant departments and answers their questions MANAGEMENT AND REPORTING * Mentors Regulatory Specialist under his/her supervision through exposure to diverse experiences across portfolios, products, regions and activities. Proposes actions for personal development to the management. * Ensure oversight of LRA : Participation to recruitment of LRA heads, Animation of the IC and CIS LRA community with a focus on LRA capabilities upgrade, periodic team and individuals face to face * Provide required input and technical support to LRA, in particular: Required adaptations of core materials to local specificities, Ad hoc preparation and participation to key meetings with local health authorities, Ad hoc first line contact to answer questions from authorities * MONITOR LOCAL REGULATORY ROADMAP IMPLEMENTATION (registration, maintenance & variations) * When relevant provides technical and scientific mentorship to a less experienced Regulatory Coordinator / GRA Team Member and whenever necessary, delegates part of his/her projects to Coordinator / GRA Team Member (eg. Internship) consistently with the professional maturity thereof * Ensures adequate reporting of his/her activities, and participation to various meetings. Supports and voices the regulatory position consistent with the regulatory strategy and tactics validated by the management of the regulatory function. Provides adequate information to Ipsen reporting tools * Ensures that registration status/data capture is adequately reported in the relevant tools / databases through data entry EXPERIENCE / QUALIFICATIONS Formation / Diploma / Certificate : PhD in SCIENTIFIC discipline (Pharmacy, Chemistry, Biological sciences) Experience : * MANAGERIAL experiences, with direct and/or transversal responsibilities 3 years minimum * Experience in REGULATORY activities obtained through professional experience, proven track record in leading geographical regulatory affairs for at least 5 years * Expertise in pharmaceutical products development, registration * Knowledge of market access requirements and needs in EU * Expertise in EU registration procedures (centralized, MRP, DCP) Language : * Fluent in English if not mother tongue REQUIRED COMPETENCIES * Excellent written and communication oral skills * Confirmed Managerial skills * Negotiation skills * Ability to influence * Strong organisational skills * Multi-cultural awareness and sensitivity with significant stay in a foreign country Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.