Regulatory Affairs Manager – Biosimilars
INSUD PHARMA operates across the entire pharmaceutical value chain, bringing specialist knowledge and experience in scientific research, development, manufacturing, sales, and commercialization of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products for both human and animal health. The company is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries. INSUD PHARMA is committed to innovation and sustainable development to deliver solutions that positively impact global health.
Responsibilities
* Lead the regulatory strategy for innovative and biosimilar products.
* 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.
Qualifications
* 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.
Benefits
* Permanent contract.
* Professional development and continuous training.
* Innovative projects with high impact on health.
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