Biologics Regulatory Affairs Manager

Cencora; Madrid; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical service provider in Madrid is looking for a Regulatory Affairs Manager to support CMC biologics activities. The role requires at least seven years of biotech industry experience and strong communication skills. The ideal candidate will lead projects and manage client relationships while ensuring regulatory compliance. This full-time position offers a chance to make a significant impact in healthcare.

Formación

• Established experience in regulatory affairs activities including Module 3 IND / IMPD authoring.
• At least seven years of experience in the biotech industry.
• Excellent written and verbal communication skills.

Responsabilidades

• Lead and support CMC biologics activities for PharmaLex projects.
• Provide a broad range of regulatory affairs support to clients.
• Manage clients and other stakeholders effectively.

Conocimientos

Proofreading

Adobe Acrobat

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Educación

Relevant science degree

Higher degree in pharmaceutical discipline

Descripción del empleo

A leading pharmaceutical service provider in Madrid is looking for a Regulatory Affairs Manager to support CMC biologics activities. The role requires at least seven years of biotech industry experience and strong communication skills. The ideal candidate will lead projects and manage client relationships while ensuring regulatory compliance. This full-time position offers a chance to make a significant impact in healthcare.