Descripción de la oferta
Regulatory Affairs Manager - Biosimilars
Experience: 5+ years in Regulatory Affairs within biotech/biopharma
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.
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.
Ready 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 global, cross-functional teams.
Monitor changes in the regulatory landscape, identify their impact, and propose solutions to maintain compliance.
Define regulatory strategy for each product in coordination with Management and Business teams.
Support the review of license and quality agreements for targeted geographies.
Organize the regulatory submission schedule and coordinate with Regulatory Affairs teams.
Manage regulatory information and ensure data integrity.
Actively participate in scientific committees and project teams.
5+ years of experience in Regulatory Affairs within biotechnology, biopharma, or biosimilars.
~ Fluent in Spanish and English (other languages are a plus).
~ Advanced skills in Microsoft Office (Word, Excel, PowerPoint, Project) and regulatory software.
~ Inspiring, influential, results-oriented with excellent communication skills.
Permanent contract
&##Professional development & continuous training
&##Innovative projects with high impact on health
1–2 interviews (virtual and/or on-site) with HR and technical teams.
~
