PbIn a nutshell /b /ppPosition: Regulatory Affairs Manager - Biosimilars /ppLocation: Madrid (on-site) /ppExperience: 5+ years in Regulatory Affairs within biotech/biopharma /ppbr/ppbWant to know more? /b /ppINSUD 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. /ppOur 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. /ppbr/ppbReady to be a #Challenger at INSUD PHARMA? /b /ppbr/ppbWhat are we looking for? /b /ppWe are seeking a Regulatory Affairs Manager to lead the regulatory strategy for our innovative and biosimilar products, ensuring compliance and collaborating with global, cross-functional teams. /ppbKey Responsibilities: /b /pulliMonitor changes in the regulatory landscape, identify their impact, and propose solutions to maintain compliance. /liliDefine regulatory strategy for each product in coordination with Management and Business teams. /liliBuild strong collaborative partnerships with internal and external teams to ensure organizational success and patient safety. /liliIdentify and mitigate regulatory risks, adapting strategies to evolving regulations and Health Authority feedback. /liliInterpret and communicate legislative changes that affect product registration, manufacturing, or development. /liliSupport the review of license and quality agreements for targeted geographies. /liliLead engagement with Health Authorities during Scientific Advice procedures and responses to deficiency letters. /liliPrepare, review, and approve regulatory submission documents (briefing packages, IBs, INDs, CTAs, MAAs, etc.). /liliManage external consultants and vendors for regulatory activities. /liliSupport product launch activities, ensuring regulatory risks are managed with appropriate action plans. /liliOrganize the regulatory submission schedule and coordinate with Regulatory Affairs teams. /liliParticipate in product plan development, regulatory strategy, and CMC documentation. /liliDrive digitalization and the use of computerized systems within the department. /li /ulpbr/ppbThe challenge! /b /p