Regulatory Affairs Manager - Biosimilars (Castro Urdiales)
I
Insud Pharma
📍 castro, kingdom of spain, Spain
Job Description
Position
¿Posee las habilidades y la experiencia adecuadas para este puesto? Siga leyendo para descubrirlo y envíe su solicitud.
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 geographies.
Lead enga...
¿Posee las habilidades y la experiencia adecuadas para este puesto? Siga leyendo para descubrirlo y envíe su solicitud.
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 geographies.
Lead enga...