Regulatory Affairs Associate - Temporary, Madrid (On-Site)

Exeltis; Madrid; Presencial; EUR 42.000 - 65.000; Jornada completa

Descripción de la vacante

Exeltis is a pharmaceutical company seeking a Regulatory Affairs Associate to support regulatory development and lifecycle management of pharmaceutical products in Madrid on-site. You will prepare eCTD modules, manage submissions and renewals, archive documents, and collaborate with Clinical Operations in the US as needed.

3+ years of regulated industry experience and fluent English are required. Join a dynamic team and help ensure timely regulatory filings while staying up-to-date with ICH,

Formación

• Bachelor’s degree in Health Sciences, preferably Pharmacy.
• 3+ years of relevant experience in regulated/pharma industry.
• Fluent English, written and spoken.
• Knowledge of ICH, GCP, regulations and directives.
• Willingness to travel.
• Experience with or understanding of eCTD documentation.

Responsabilidades

• Prepare and validate eCTD modules for regulatory submissions.
• Archive Product Information per procedures.
• Provide documents for national submissions to local affiliates.
• Submit renewals on time and track timelines.
• Support regulatory activities related to US clinical trials.
• Track and archive regulatory submissions.

Conocimientos

Fluent English

Attention to detail

Autonomy

Educación

Bachelor's degree in Health Sciences (Pharmacy preferred)

Herramientas

eCTD documentation

Descripción del empleo

Exeltis is a pharmaceutical company seeking a Regulatory Affairs Associate to support regulatory development and lifecycle management of pharmaceutical products in Madrid on-site. You will prepare eCTD modules, manage submissions and renewals, archive documents, and collaborate with Clinical Operations in the US as needed.

3+ years of regulated industry experience and fluent English are required. Join a dynamic team and help ensure timely regulatory filings while staying up-to-date with ICH,