Seasoned regulatory affairs professional specialized in development, registration & maintenance of medicinal products, with broad understanding of international regulations, processes and issues in drug development leading a team of regulatory, publishing, scientific writing and pharmaceutical development experts. email: nadia.boehringer@pharmalex.com or call +33 (0)6 38 41 41 17The Pharmalex Group is one of the world's leading providers of specialized services to the pharmaceutical, biotechnology and medical device industries.More information on www.pharmalex.comPast & Current Experience :Development & submission of global regulatory filings for new medicinal product and line extension with proven track record of successful registrations worldwide. Participation in the development of global regulatory strategy and implementation plans. Regulatory advice & expertise to global cross-functional teams on project-related regulatory matters for development & registration activities. Involvement in the strategy & writing of PIP, protocol, IB, IMPD, briefing package, ODD and due diligence. Regulatory support to clinical trials I to III. Selection of CRO partners for reg activities. Development of regulatory risk management and contingency plans.Contribution to the regional strategic input of TPP,CDS. Interaction with regulatory agency (pre-submission, follow-up, scientific advice). Maintenance of approved product applications in compliance with regulatory filing requirements (variations, renewals, CMC & labeling compliance projects). Involvement in brand optimization strategies & life-cycle management for Rx & OTC products. Review of corporate promotional elements as per EFPIA guidelines.Coordination of regulatory team including affiliates & partners (>150 people) by providing leadership & mentoring so as to ensure respect of objectives in timely manner. Oversight Project Manager in development/registration and LCM Working with other functions and functional management to ensure appropriate budget & resources to meet objectives. Management of relevant project budgets to ensure compliance with agreed parameters, reporting & updates. Management of the business development, business plan of units/offers & contracts coordination as consultant.Member of the leadership team.