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CMC Regulatory Specialist - Pharma
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Biotechnology and Pharmaceutical organization, based in Basel-Landschaft Switzerland.
Our client is focused on finished pharmaceutical products.
Manage/lead regulatory CMC projects
Management of time-lines and submission planning
Communicate CMC issues
Provide CMC regulatory guidance to project teams
Manage the preparation, writing and functional review of global CMC documents (modules 3 and 2.3) for new marketing applications, responses to health authorities and post-approval variations
Participate in interdisciplinary change management and evaluate the regulatory relevance of proposed CMC-changes
University degree in pharmacy, chemistry, life science or similar education
Minimum 4 years of experience in CMC Regulatory Affairs in the pharmaceutical industry
Solid experience in CTD module 3 handling and life-cycle management of market applications worldwide
Knowledge in preparation of CMC dossier in support of clinical trials (IMPD/IND) would be a plus
Fluency in English & German (both negotiation skills)
Reliable team-player, with strategic thinking and sense for practical solutions
Good communication skills and able to work independently on multiple tasks and under pressure in an organized manner
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.