Regulatory Affairs Manager - Biosimilars
brExperience: 5+ years in Regulatory Affairs within biotech/biopharma
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brINSUD PHARMA operates across the entire pharmaceutical value chain, bringing specialist knowledge and experience in scientific research, development, manufacturing, sales, and commercialization of a broad range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value in both human and animal health.
brOur activities are organized in three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries. We are committed to innovation and sustainable development to deliver solutions that positively impact global health.
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brReady to be a #Challenger at INSUD PHARMA? ##We are seeking a Regulatory Affairs Manager to lead the regulatory strategy for our innovative and biosimilar products, ensuring compliance and collaborating with general, cross-functional teams.
brMonitor changes in the regulatory landscape, identify their impact, and propose solutions to maintain compliance.
brDefine regulatory strategy for each product in coordination with Management and Business teams.
brSupport the review of license and quality agreements for targeted geographies.
brOrganize the regulatory submission schedule and coordinate with Regulatory Affairs teams.
brManage regulatory information and ensure data integrity.
brActively participate in scientific committees and project teams.
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br5+ years of experience in Regulatory Affairs within biotechnology, biopharma, or biosimilars.
br~ Fluent in Spanish and English (other languages are a plus).
br~ Advanced skills in Microsoft Office (Word, Excel, PowerPoint, Project) and regulatory software.
br~ Inspiring, influential, results-oriented with excellent communication skills.
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brPermanent contract
br##Professional development continuous training
br##Innovative projects with high impact on health
br1–2 interviews (virtual and/or on-site) with HR and technical teams.
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