Regulatory Affairs Manager - Pharma (Vitoria-Gasteiz)

Regulatory Affairs Manager – Biosimilars

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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, finished dosage forms, and branded products. The company has three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience).
Responsibilities

Lead the regulatory strategy for innovative and biosimilar products, ensuring compliance and collaborating with global cross‑functional teams.
Monitor regulatory landscape changes, assess 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.
Permanent contract.
Benefits

Professional development & continuous training. xqbhyrx
Innovative projects with high impact on health.

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