Associate, Regulatory Affairs en Madrid

Descripción del empleo

We're looking for a detail-oriented and driven Associate, Regulatory Affairs to join our client's Regulatory Affairs team. This is a fantastic opportunity to contribute to high-quality FDA submissions and help bring innovative therapies to market.

What You'll Do:

• Support the preparation, review, and submission of regulatory documents including NDAs, amendments, supplements, and annual reports.
• Collaborate cross-functionally to gather and verify documentation for timely submissions.
• Review technical documents for accuracy and regulatory compliance.
• Draft clear and concise responses to FDA inquiries under supervision.
• Track and maintain regulatory databases and spreadsheets.
• Monitor regulatory changes and assess their impact on the business.
• Provide administrative support and manage communications with regulatory agencies as needed.

What You Bring:

• Bachelor's degree in a life science discipline.
• 3+ years of experience in the pharmaceutical industry, with at least 1-2 years in regulatory affairs.
• Strong understanding of FDA guidelines and regulatory requirements.
• Excellent written and verbal communication skills.
• High attention to detail, strong analytical thinking, and sound judgement.
• Ability to manage multiple priorities in a fast-paced environment.

Información extra

Status

Activa

Estudios requeridos

E.S.O

Localización

Madrid

Tipo de contrato

Trabajo estudiantes

Publicado el

01-08-2025

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Español