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Regulatory Affairs Manager M/W Lyon France,  


Posted on : 05 July 2017

Project Description

Company presentation : Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins. Adocia's insulin formulation portfolio, featuring four clinical-stage products and one preclinical product, is among the largest and most differentiated in the industry. Job presentation : Within a multidisciplinary team of 130 people, you will actively participate in product development whilst working in close collaboration with other members of the Research and Development team. The mission entails: " Participating in the development and implementation of regulatory strategy for the company's projects, " Identifying and defining the regulatory issues regarding CMC as well as nonclinical and clinical development, " Interpreting the regulations and providing and informing teams of regulatory guidelines, " Advising and assisting the different departments on regulatory aspects, " Drafting and/or revising various regulatory documents such as IMPD, IND and IB, " Managing the preparation of documents and answers to queries posed by health authorities, " Identifying the relevant regulatory experts and supervising their services, " Monitor regulatory changes and developments on an international level, and anticipate future regulatory trends. Profile : With a higher education in a relevant scientific field (postgraduate level), the ideal candidate would have at least 5 years' experience in a similar role within the pharmaceutical industry, as well as the following skills: " An excellent command of English, both written and oral, " Excellent interpersonal skills and a flair for teamwork. Passionate about Science and Innovation, you are motivated by an ambitious, competitive and promising environment. Adocia promotes excellence in order to become a valuable partner to large pharmaceutical corporations specialized in the innovative treatment of chronic diseases. Qualified candidates should contact: G

Locations

69003 Lyon France

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