Regulatory Affairs Manager - Biosimilars (Foz)

In a nutshell: ¿Todo listo para enviar su solicitud? Por favor, lea la descripción al menos una vez antes de hacer clic en Solicitar. Position: Regulatory Affairs Manager - Biosimilars. Location: Madrid (on-site). Experience: 5+ years in Regulatory Affairs within biotech/biopharma.

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 to evolving regulations and Health Authority feedback.
• Interpret and communicate legislative changes that affect product registration, manufacturing, or development.
• Support the review of license and quality agreements for targeted ...