Regulatory Affairs Manager - Biosimilars

Position: Regulatory Affairs Manager – Biosimilars

Location: Madrid (on-site)

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, finished dosage forms and branded pharmaceutical products, adding value in both human and animal health.

Key Responsibilities

• 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.
• Build strong collaborative partnerships with internal and external teams to ensure organizational success and patient safety.
• Identify and mitigate regulatory risks, adapting strategies...