Regulatory affairs manager - biosimilars (La Línea de la Concepción)
Insud Pharma
Full-time
Gestión y operaciones
Location
la línea de la concepción, andalucía, Spain
Posted
July 02, 2026
Job Description
About the Position
Regulatory Affairs Manager – BiosimilarsLocation: Madrid (on‑site)Experience: 5+ years in Regulatory Affairs, biotech/biopharma, or biosimilars.
Key Responsibilities
- Monitor changes in the regulatory landscape, identify impacts, and propose compliance solutions.
- Define and coordinate regulatory strategy for each product with management and business teams.
- Build collaborative partnerships with internal and external teams to ensure organisational success and patient safety.
- Identify and mitigate regulatory risks, adapting strategies to evolving regulations and Health Authority feedback.
- Interpret and communicate legislative changes affecting product registration, manufacturing, or development.
- Support review of license and quality agreements for targeted geographies.
- Lead engagement with Health Authorities during Scientific Advice procedures and responses to deficiency letters.