Global Regulatory Project Manager

il y a 15 heures

BoulogneBillancourt, France Pierre Fabre Laboratories Temps plein

Global Regulatory Project Manager - M/F/ Permanent position based in Boulogne (92) or Toulouse (31). We are recruiting a Global Regulatory Project Manager on a permanent contract to join the Worldwide Regulatory Affairs teams of the Medical Care Business Unit, covering the International Pharmaceutical Care scope (excluding Europe). In alignment with global product regulatory and commercial strategies, you will define, plan and coordinate the implementation of the regulatory strategy for all projects relating to registration, maintenance of Marketing Authorisations (or other status) and business development within your assigned geographical area, ensuring objectives are met in accordance with pharmaceutical regulations. You will serve as the primary Corporate contact for country-specific regulations within your scope and provide necessary support to local regulatory contacts for local business development. You will also drive effective coordination of project teams’ work within and in collaboration with worldwide Regulatory Affairs in the course of your activities. Your Role within a Pioneering and Fast-Growing Company Specifically, you will: Ensure regulatory requirements and changes are considered in the definition of the global product regulatory strategy and in carrying out your activities. Anticipate, analyse, define, plan and adapt regulatory strategies related to registrations, variations, and maintenance of projects/products on the markets. Prepare the necessary information for compiling applications and maintenance dossiers for Marketing Authorisations in collaboration with local contacts and other departments/professions, and ensure submission follow-up. Manage submission schedules in coordination with the Franchise lead and contribute to budget planning. Develop and maintain close relationships with local regulatory contacts (internal PF or local partners). Provide relevant information, advice or regulatory support within your scope to other Corporate departments (Development, BI, Production, etc.). This position allows up to two days per week of remote working after the probation period. We offer an attractive remuneration and benefits package: Profit-sharing, employee share ownership with company contribution, health and welfare insurance, 16 additional RTT days on top of paid holidays, and public transport subsidy. Profile You have a scientific background at Bac+5 level (Pharmacist, Chemist, or equivalent) and at least five years’ experience in International Regulatory Affairs. A first experience in Development would be an advantage. You possess a very good professional standard of English (minimum C1 level). You use MS Office and regulatory databases/documentation tools daily. We are convinced that diversity is a source of fulfilment, social balance and complementarity for our employees, so all our vacancies are open to everyone without restriction. Do you want to take care of your career by joining a committed company? Join us Seniority level Associate Employment type Full-time Job function Science, Project Management, and Research Industries Pharmaceutical Manufacturing #J-18808-Ljbffr

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