Regulatory Affairs Lead – International Projects (Temporary)

Insud Pharma; Madrid; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Exeltis, part of Insud Pharma, Madrid, is seeking a Regulatory Affairs Associate to provide regulatory leadership and manage LPRI projects for international markets. The role requires defining regulatory strategy, planning submissions, and liaising with agencies to ensure timely approvals.

Fluent English and Spanish are required, with 3+ years in the pharmaceutical sector and strong knowledge of EMA regulations and centralised/decentralised dossiers. This is a temporary position in Madrid.

Formación

• Degree in Sciences (Pharmacy preferred); Master’s a plus.
• Fluent English and Spanish; additional languages a plus.
• 3+ years in pharmaceutical Regulatory Affairs with international exposure.

Responsabilidades

• Provide regulatory leadership for LPRI projects for international markets.
• Develop and implement regulatory strategies for development projects.
• Coordinate with regulatory agencies and plan filings for Europe.
• Oversee eCTD submissions and variations with stakeholders.
• Support product acquisitions and regulatory process improvements.

Conocimientos

Regulatory leadership

Cross-functional coordination

Regulatory submissions

Educación

Pharmacy degree

Master’s degree

Herramientas

eCTD submissions

Descripción del empleo

Exeltis, part of Insud Pharma, Madrid, is seeking a Regulatory Affairs Associate to provide regulatory leadership and manage LPRI projects for international markets. The role requires defining regulatory strategy, planning submissions, and liaising with agencies to ensure timely approvals.

Fluent English and Spanish are required, with 3+ years in the pharmaceutical sector and strong knowledge of EMA regulations and centralised/decentralised dossiers. This is a temporary position in Madrid.