Pb In a nutshell /b /pp Position: Regulatory Affairs Manager - Biosimilars /pp Location: Madrid (on-site) /pp Experience: 5+ years in Regulatory Affairs within biotech/biopharma /p pb Want to know more? /b /pp INSUD 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. /pp Our 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. /p pb Ready to be a #Challenger at INSUD PHARMA? /b /p pb What are we looking for? /b /pp We 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. /ppb Key Responsibilities: /b /pulli Monitor changes in the regulatory landscape, identify their impact, and propose solutions to maintain compliance. /lili Define regulatory strategy for each product in coordination with Management and Business teams. /lili Build strong collaborative partnerships with internal and external teams to ensure organizational success and patient safety. /lili Identify and mitigate regulatory risks, adapting strategies to evolving regulations and Health Authority feedback. /lili Interpret and communicate legislative changes that affect product registration, manufacturing, or development. /lili Support the review of license and quality agreements for targeted geographies. /lili Lead engagement with Health Authorities during Scientific Advice procedures and responses to deficiency letters. /lili Prepare, review, and approve regulatory submission documents (briefing packages, IBs, INDs, CTAs, MAAs, etc.). /lili Manage external consultants and vendors for regulatory activities. /lili Support product launch activities, ensuring regulatory risks are managed with appropriate action plans. /lili Organize the regulatory submission schedule and coordinate with Regulatory Affairs teams. /lili Participate in product plan development, regulatory strategy, and CMC documentation. /lili Drive digitalization and the use of computerized systems within the department. /li /ul pb The challenge! /b /pulli Oversee the preparation and submission of regulatory documentation. /lili Coordinate regulatory strategy with RD, QA, QC, and Production teams. /lili Lead negotiations and presentations with regulatory agencies. /lili Manage regulatory information and ensure data integrity. /lili Actively participate in scientific committees and project teams. /li /ul pb What do you need? /b /pulli University degree in Health Sciences (preferably Pharmacy; degrees in Chemistry, Biology, Biochemistry, Veterinary or similar will also be considered). /lili5+ years of experience in Regulatory Affairs within biotechnology, biopharma, or biosimilars. /lili In-depth knowledge of pharmaceutical legislation, GMP, and ICH guidelines. /lili Fluent in Spanish and English (other languages are a plus). /lili Advanced skills in Microsoft Office (Word, Excel, PowerPoint, Project) and regulatory software. /lili Willingness to travel. /lili Inspiring, influential, results-oriented with excellent communication skills. /li /ul pb Our benefits! /b /pp Permanent contract /pp Professional development continuous training /pp International and multidisciplinary environment /pp Innovative projects with high impact on health /pp What’s the selection process like? ️ /pulli Initial contact by phone or email. /lili1–2 interviews (virtual and/or on-site) with HR and technical teams. /lili Ongoing updates throughout your recruitment process. /li /ul pb Not the right fit for you? /b /pp Follow us on LinkedIn to stay updated on future opportunities and news from INSUD PHARMA. We’d love to connect! /pp#InsudPharma #Challenger #Insuder #InsudTalent /p p COMMITMENT TO EQUAL OPPORTUNITIES /pp At INSUD PHARMA, we promote gender equality and do not discriminate based on ethnicity, religion, sexual orientation, disability, or any other condition. We firmly believe that diversity and talent drive innovation and growth. /p